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Objectives: We aimed to compare plasmapheresis and medical apheresis as lipid-lowering therapies in children with familial lipoprotein lipase (LPL) deficiency., Methods: The data of 13 patients who were followed up after a diagnosis of LPL deficiency were retrospectively analyzed. Plasma triglyceride, cholesterol, amylase, and lipase values and complications were recorded before and after each patient underwent plasmapheresis or medical apheresis., Results: The mean follow-up period of the patients was 99.64 ± 52.92 months in the medical apheresis group and 118 ± 16.97 months in the plasmapheresis group. While the mean triglyceride level before plasmapheresis was 1,875.38 ± 547.46 mg/dL, it was 617 ± 228.28 mg/dL after plasmapheresis. While the mean triglyceride level before medical apheresis was 1,756.86 ± 749.27 mg/dL, it was found to be 623.03 ± 51.36 mg/dL after medical apheresis. Triglyceride levels were decreased by 59.62% with medical apheresis and 65.57% with plasmapheresis. The cost of treatment for medical apheresis was found to be lower compared to plasmapheresis 296.93 ± 29.94 Turkish lira (USD 43.34 ± 4.01) vs. 3,845.42 ± 156.17 Turkish lira (USD 561.37 ± 20.93; p<0.001)., Conclusions: Although there is no standardized strategy for the acute treatment of hypertriglyceridemia due to LPL deficiency, medical apheresis is a safe and effective treatment with a low risk of side effects. Unlike plasmapheresis, medical apheresis can be performed in any center, which is another important advantage of the procedure., (© 2021 Walter de Gruyter GmbH, Berlin/Boston.)

Voluntary, anonymous free gift-giving has become the dominant norm for blood donation for transfusion purposes, in view of its established ability to satisfy the needs for labile blood products that meet satisfactory conditions of safety and cost. But the economy of blood products is also the place for one of the main exceptions to the principle of non-commercialization of body parts. I show that there exists a genuine international plasma market, which provides the raw materials to produce blood protein products by pharmaceutical industries. The recent years have seen a considerable strengthening of the massive and globalized features of this market. I briefly describe the issues that this evolution raises, and I sketch some directions for a partial resolution of these issues. I explain why the development of contract fractionation appears both possible and desirable from an economic perspective in the present context., (Copyright © 2019 Société française de transfusion sanguine (SFTS). Published by Elsevier Masson SAS. All rights reserved.)

Introduction: Multiple sclerosis (MS) is an autoimmune disorder with large annual costs. This study evaluated utilization and costs for the management of MS relapses with H.P. Acthar(®) Gel (repository corticotropin injection; Acthar; Mallinckrodt) compared to receipt of plasmapheresis (PMP) or intravenous immunoglobulin (IVIG) among patients with MS who experienced multiple relapses., Methods: We identified patients with MS diagnoses who had relapses treated with intravenous methylprednisolone (IVMP), the first-line treatment for MS relapse. Patients who were treated for the subsequent relapses were eligible for the study. We analyzed 12- and 24-month healthcare utilization and costs among patients who received Acthar prescriptions compared to patients who were treated with PMP/IVIG using generalized linear and logistic regression models to calculate unadjusted and adjusted means and 95% confidence intervals., Results: For the 12-month analysis, a total of 213 patients received Acthar prescriptions and 226 were treated with PMP or IVIG. Patients who received Acthar prescriptions were similar to those who received other treatments in terms of most demographic variables. Acthar recipients had fewer hospitalizations (0.2 vs. 0.4; P = 0.01) and received fewer outpatient services (29 vs. 43; P < 0.0001) but received more prescription medications (36 vs. 30; P < 0.0001) compared to recipients of PMP/IVIG. Patients who received Acthar prescriptions had lower inpatient and outpatient costs ($15,000 lower; P = 0.001; and $54,000 lower; P < 0.0001, respectively) but similar total costs. Similar results were seen in the cohort with 24 months of outcome data., Conclusion: Acthar may be a useful treatment option compared to PMP/IVIG for patients with MS experiencing multiple relapses., Funding: This study was funded by a grant to the University of Washington from Mallinckrodt Pharmaceuticals.

Background: For desensitization of ABO-incompatible kidney transplant recipients we recently proposed nonantigen-specific immunoadsorption (IA) and rituximab., Methods: We now compared clinical outcomes of 34 ABO-incompatible living-donor kidney recipients who were transplanted using this protocol with that of 68 matched ABO-compatible patients. In addition, we analyzed efficacy and cost of nonantigen-specific as compared to blood group antigen-specific IA., Results: Before desensitization, the median isoagglutinin titer of 34 ABO-incompatible patients was 1:64 (Coombs technique). Patients received a median of 7 preoperative IA treatments. Twenty-four patients had a median of 2 additional plasmapheresis treatments to reach the preoperative target isoagglutinin titer of 1:8 or less. After a median postoperative follow-up of 22 months, overall graft survival in the ABO-incompatible group was not significantly different from that in ABO-compatible patients (log-rank P = 0.20), whereas patient survival tended to be lower (log-rank P = 0.05). The incidence of rejection episodes was 15% in both groups. The ABO-incompatible kidney recipients had a higher incidence of BK virus replication (P = 0.04) and nephropathy (P = 0.01) and showed more often colonization with multidrug resistant bacteria (P = 0.02). In comparison to blood group antigen-specific IA, nonantigen-specific IA showed equal efficacy but was associated with reduction in cost., Conclusions: Clinical outcomes of ABO-incompatible patients desensitized with a nonantigen-specific IA device and rituximab do not differ from that of matched ABO-compatible patients although a trend toward reduced patient survival was noted. Special attention must be paid to the higher incidence of BK virus infection in recipients of ABO-incompatible grafts.

Background: In Italy, the financial reimbursement for labile blood components exchanged between Regions is regulated by national tariffs defined in 1991 and updated in 1993-2003. Over the last five years, the need for establishing standard costs of healthcare services has arisen critically. In this perspective, the present study is aimed at defining both the costs of production of blood components and the related prices, as well as the prices of plasma-derived medicinal products obtained by national plasma, to be used for interregional financial reimbursement., Materials and Methods: In order to analyse the costs of production of blood components, 12 out 318 blood establishments were selected in 8 Italian Regions. For each step of the production process, driving costs were identified and production costs were. To define the costs of plasma-derived medicinal products obtained by national plasma, industrial costs currently sustained by National Health Service for contract fractionation were taken into account., Results: The production costs of plasma-derived medicinal products obtained from national plasma showed a huge variability among blood establishments, which was much lower after standardization. The new suggested plasma tariffs were quite similar to those currently in force. Comparing the overall costs theoretically sustained by the National Health Service for plasma-derived medicinal products obtained from national plasma to current commercial costs, demonstrates that the national blood system could gain a 10% cost saving if it were able to produce plasma for fractionation within the standard costs defined in this study., Discussion: Achieving national self-sufficiency through the production of plasma-derived medicinal products from national plasma, is a strategic goal of the National Health Service which must comply not only with quality, safety and availability requirements but also with the increasingly pressing need for economic sustainability.

Hypertriglyceridemia is associated with a number of severe diseases such as acute pancreatitis and coronary artery disease. In severe hypertriglyceridemia (SHTG, triglycerides > 1,000 mg/dL), rapid lowering of plasma triglycerides (TG) has to be achieved. Treatment regimes include nutritional intervention, the use of antihyperlipidemic drugs, and therapeutic apheresis. Apheretic treatment is indicated in medical emergencies such as hypertriglyceridemic pancreatitis. Reviewing the current literature, plasmapheresis appears to be a safe and useful therapeutic tool in patients suffering from SHTG. Apheretic treatment is able to remove the causative agent for pancreatic inflammation. Data suggests that the use of apheresis should be performed as early as possible in order to achieve best results. The use of plasmapheresis, however, is limited due to the rather high costs and the limited availability of the procedure.

Living donor kidney transplantation is the preferred therapeutic option for patients with end stage renal disease. Unfortunately, about 20-30% of potential living kidney donors are rejected because of incompatible immunological barriers such as ABO incompatibility. The newest desensitization protocols based on therapeutic apheresis and perioperative immunosuppressive drugs have allowed to overcome antibody barriers. The aim of these protocols is to wash out and suppress as many anti-A or anti-B antibodies as possible and to prevent rebound phenomena after transplantation. Standard plasmapheresis, double-filtration plasmapheresis, and selective immunoadsorption are among the most common apheresis modalities applied in ABO-incompatible transplantation. Selective immunoadsorption appears to be much safer and to have markedly increased efficacy compared with plasmapheresis, as it eliminates almost exclusively blood-group antibodies, thus avoiding plasma and coagulation abnormalities. According to the literature, long-term patient and graft survival rates are similar to those achieved with ABO-compatible kidney transplants. We have used selective immunoadsorption in two ABO-incompatible kidney transplants performed at our institution. No acute rejection was observed at 12 and 32 months' follow-up and both grafts are functioning well. Despite the widespread use of ABO-incompatible kidney transplant, however, the mechanisms of accommodation, the best desensitization protocol, the upper baseline and perioperative isoagglutinin titer limit, and the most accurate isoagglutinin measurement assay are still to be defined.

Objective: To compare clinical and economic outcomes following plasma exchange (PLEX) and intravenous immunoglobulin (IVIG) in U.S. patients with primary diagnoses of myasthenia gravis (MG)., Methods: Our cohort was identified from the Nationwide Inpatient Sample database for years 2000-2005 using codes from the International Classification of Diseases, 9th edition. Multivariate regression analyses were used to identify predictors of mortality, complications, length of stay, and total inpatient cost., Results: Among 1,606 hospitalized patients, the unadjusted mortality rate of MG crisis remained higher than those without crisis (0.44% vs 4.44%, p < 0.001), as well as the unadjusted complication rate (26.36% vs 11.23%, p < 0.001). MG crisis patients receiving PLEX had significantly more complications than those receiving IVIG (30.06% vs 14.79%, p < 0.001). Among the whole cohort, adjusted mortality and complication rates were not significantly different between the treatment groups (p > 0.05). Acute respiratory failure, major cardiac complications, and acute renal failure were associated with an increased mortality rate (p < 0.001). Age and respiratory failure were associated with an increased complication rate (p < 0.001). Length of stay was significantly longer for MG (6 vs 4 days, p < 0.001) and MG crisis (10 vs 5 days, p < 0.001) patients receiving PLEX. Inpatient costs were higher for MG ($26,662 vs $21,124, p < 0.01) and MG crisis ($53,801 vs $33,924, p < 0.001) patients receiving PLEX., Interpretation: Compared to PLEX, IVIG appears of similar clinical (mortality and complications) and perhaps of superior economic (length of stay and total inpatient charges) outcomes in the treatment of MG. Elderly and those with complex comorbid diseases including acute respiratory failure may be better treated with IVIG.

Objectives: To assess whether intravenous immunoglobulin (IVIG) followed by plasma exchange (PE) is more effective for patients with Guillain-Barré syndrome compared with IVIG alone., Methods: Retrospective chart review of 46 patients treated for Guillain-Barré syndrome between 1995 and 2005 was performed. Patients were divided into four subgroups based on treatment received (IVIG, PE, IVIG + PE, or neither). Disability grade on admission, after completion of IVIG, and on the day of discharge from hospital (DGD) were assessed. DGD was the primary outcome measure. Duration of hospitalization, costs, duration of symptoms before treatment, and interval between IVIG and initiation of PE were analyzed., Results: Mean disability grade on admission was similar for all groups. DGD was significantly lower for the IVIG group (P < 0.001) than other groups. Compared with admission, patients treated with IVIG + PE had more severe impairment after completion of IVIG (P = 0.044) but did not show significant improvement after PE. Disability grade on admission and DGD scores for patients treated earlier (less than 14 days after onset of symptoms) versus later (greater than 14 days) were not significantly different. Duration of hospitalization was longer in patients receiving IVIG + PE versus IVIG alone (P < 0.001). The cost of treatment was significantly higher in the IVIG + PE subgroup (P < 0.001). No correlation between interval from IVIG to PE onset and DGD score was found., Conclusions: We found no association between PE after IVIG and improved short-term outcomes of patients with Guillain-Barré syndrome, but there was an association with an increase in cost and duration of hospitalization. There was no association between the timing of PE after IVIG and the short-term outcome. Prospective studies are needed to clarify whether the cost/benefit ratio favors the routine use of this therapeutic approach.

Objective: Paid plasma donation has contributed to HIV epidemics in many countries. Eleven million liters of plasma are fractionated annually in the U.S., mainly from paid donors. Deferral of high-risk donors such as injection drug users (IDUs) is required for paid donations. We studied circumstances surrounding paid plasma donation among IDUs in two Mexico-U.S. border cities., Methods: In 2005, IDUs > or = 18 years old in Tijuana (N=222) and Cd. Juarez (N=206) who injected in the last month were recruited through respondent-driven sampling. Subjects underwent antibody testing for HIV and HCV and an interviewer-administered survey including questions on donating and selling whole blood and plasma., Results: Of 428 IDUs, HIV and HCV prevalence were 3% and 96%, respectively; 75 (17.5%) reported ever having donated/sold their blood or plasma, of whom 28 (37%) had sold their plasma for an average of $16 USD. The majority of IDUs selling plasma were residents of Ciudad Juarez (82%); 93% had sold their plasma only in the U.S. The last time they sold their plasma, 65% of IDUs had been asked if they injected drugs. Although the median time since last selling plasma was 13 years ago, 3 had done so within the prior 2 years, one within the prior 6 months; of these 3 IDUs, 2 were from Cd. Juarez, one from Tijuana; all 3 had only sold their plasma in the U.S., Conclusions: Although selling plasma appears uncommon among IDUs in these two Mexican border cities, the majority sold plasma in the U.S. and only one-third were deferred as high-risk donors. Paying donors for plasma should be a matter of public inquiry to encourage strict compliance with regulations. Plasma clinics should defer donors not only on behavioral risks, but should specifically inspect for injection stigmata.

It is necessary to rethink, from time to time, the efficacy of various treatment methods and, consequently, their place in the curing of certain pathological conditions. History of the development of methods throws a light on the fact that it is not always a question to be solved that brings about research; but there are cases when a technique realized for a totally different purpose is being used as a therapeutic process. In autoimmune illnesses, the plasmapheresis therapy is not of recent origin; in spite of that, however, a number of experiences, collected in the treatment of illnesses having divergent pathological symptoms, is not sufficient in itself to establish effectiveness without random double-blind tests. Intervention trying to obtain results under any circumstances (heroic medicine) is to be avoided. When evaluating results in general, however, we must take into consideration the proportion of costs also (cost/benefit principle).

Several protocols allow for the successful transplantation of sensitized renal allograft recipients, yet no one best method has emerged. The aim of the current study was to compare the efficacy of high-dose IVIG with two different plasmapheresis (PP)-based regimens in kidney transplant recipients with high levels of donor specific alloantibody (DSA) defined as a positive T-cell cytotoxicity crossmatch. With the primary goal of achieving a negative crossmatch, we employed three protocols sequentially between April 2000 and May 2005: (i) PP, low-dose IVIG, anti-CD20 antibody (n = 32); (ii) high-dose IVIG (n = 13); and (iii) PP, low-dose IVIG, anti-CD20 antibody and pre-transplant Thymoglobulin combined with post-transplant DSA monitoring (n = 16). IVIG decreased DSA activity in all treated patient, yet only 38% (5/13) achieved a negative crossmatch. In contrast, a negative crossmatch was achieved in 84% in PP group and 88% in the PP/monitoring group (p < 0.01 vs. IVIG). Even with a negative crossmatch, the rejection rates were 80% (IVIG), 37% (PP) and 29% (PP/monitoring), respectively, (p < 0.05 IVIG vs. PP). We conclude that multiple PP treatments leads to more reproducible desensitization and lower humoral rejection rates than a single high-dose of IVIG, but that no regimen was completely effective in preventing humoral rejection.

The commercial plasma industry and blood trade can fuel the transmission of HIV in a community by the most efficient way in which HIV is transmitted: the parenteral route. Paid donors get infected at the time of donation through practices like the re-use of needles, and/or injecting human blood. Paid donors from developing countries are a major source for plasma used by the pharmaceutical industry, that in 1999 fractionated 26 million litres. Paid donors also constitute an important source of blood for local use, contributing to rapid transmission of HIV through blood transfusion. This happened in Mexico in the 1980s and more recently in China. This route of HIV transmission can be efficiently prevented through a global safe blood programme and there is an urgent need to combat the epidemic.

This paper presents cost-effectiveness analyses (CEAs) of plasma collection via two alternative methods: whole blood collection (WBC) and erythroplasmapheresis collection (EPC). The objective of the study is to provide an answer to the question 'What is the least-cost method of plasma production'. This question is answered, both from the viewpoint of the blood collection agency (using financial CEA) and from that of 'society' as a whole (using economic CEA). We employ detailed financial data and economic survey data for collections made by a blood collection agency and to WBC and EPC donors in Brisbane, Australia. The results indicate that, despite the superior yield provided by EPC, WBC is actually more cost-effective. This result is robust to thorough sensitivity analysis and arises regardless of whether an economic or financial perspective is taken. We conclude that, ceteris paribus, the cost of recruiting new plasma donors would need to be quite substantial for marginal investments in EPC to be considered cost-effective.

Purpose: Cost analysis of autologous blood conservation measures compared to corresponding homologous blood products., Methods: This study is based on data from 5,017 patients undergoing major bone and joint surgery in 1993 and participating preoperatively in autologous blood donation (ABD) (with hemoseparation (HS) into autologous packed red blood cells (APRBC) and autologous fresh-frozen-plasma (AFFP)), autologous plasmapheresis (APPH) for harvesting AFFP as well as intra-/postoperative blood salvage with mechanically processed autologous transfusion (MAT)., Results: Total costs for 3,110 ABD with HS amount to DM 517,586.00 resulting in about DM 167.00 per U of APRBC plus AFFP. Comparatively, costs per U of HPRBC is about DM 202.00. Break-even-point (BEP) is calculated with 2,258 U of APRBC (without considering AFFP additionally obtained by HS). Taking into account this AFFP due to coagulation in 20% lowers BEP to 1,819 U of APRBC. However, this analysis compares the "mere" cost figures only, but does not consider the extent of ABD-induced increase in rbc mass compared to that of HPRBC. Under these circumstances calculated cost per unit of APRBC is up to 90 per cent higher than for 1 U of HPRBC. Total cost for PPH with 15,570 U of AFFP amounts to about DM 1,824,162.00, resulting in about DM 115.00 per U of AFFP. Comparatively, cost per U of HFFP is about DM 136.00. BEP is calculated with 11,595 U of AFFP. However, when considering AFFP on coagulatory reasons' with 20% only, no BEP can be calculated and AFFP is not proven to be cost-efficient. Under these conditions it is about 2.8-times more expensive than HFFP; and if considering AFFP a volume substitute it is even more than twelve times more expensive than artificial colloids (e.g. HES 6%, 200/0.5). MAT--2,690 sets and patients with a total of 5,326 processing cycles--causes a total cost of about DM 1,356,161.00, resulting in about DM 504.00 per set and patient. Under our conditions MAT is not cost-efficient compared to HPRBC as it is about two times more expensive than HPRBC. For reaching cost efficiency the number of processing cycles is either to be increased from about 2 to about 4 cycles per set and patient or hematocrit of the rbc-product obtained by MAT is clearly to be increased., Conclusions: The "mere" figures of this cost analysis of APRBC versus HPRBC as well as of AFFP versus HFFP and HES appear in favour of the autologous products. However, such an analysis should consider--besides the costs--both the increase in rbc-mass obtained by ABD or MAT, versus homologous rbc, and the indication for administering AFFP. This study does not prove our autologous blood conservation measures to be cost efficient compared to homologous blood products. Therefore, these data may cause a critically reflection on established concepts of autologous transfusion measures and may initiate promoting new and more cost efficient constellations/alternatives of blood conservation measures.

Platelet-rich plasmapheresis (PRP) just prior to cardiopulmonary bypass (CPB) surgery is used to improve post CPB hemostasis and to minimize the risks associated with exposure to allogeneic blood and its components. Meta-analysis examines evidence of PRP's impact on clinical outcomes by integrating the results across published research studies. Data on clinical outcomes was collected from 20 published studies. These outcomes, DRG payment rates, and current national average costs were used to examine the impact of PRP on costs. This study provides evidence that the use of PRP results in improved clinical outcomes when compared to the identical control groups not receiving PRP. These improved clinical outcomes result in subsequent lower costs per patient in the PRP groups. All clinical outcomes analyzed were improved: blood product usage, length of stay, intensive care stay, time to extubation, incidence of cardiovascular accident, and incidence of reoperation. The most striking differences occur in use of all blood products, particularly packed red blood cells. This study provides an example of how initial expenditure on technology used during CPB results in overall cost savings. Estimated cost savings range from $2,505.00 to $4,209.00. More importantly, patients benefit from improved clinical outcomes.

In 1986 an epidemic of HIV infection among paid plasma donors was identified in Mexico; paid donors were iatrogenically infected in a plasmapheresis center. These paid donors sold both plasma and blood: they provided one-third of blood consumed in 1986. This led to infection of blood recipients, mainly women of childbearing age. Blood transfusion is the leading cause of AIDS in women in Mexico. The male:female ratio decreased from 30:1 in 1986 to 5:1 1990; that coincided with the increase of transfusion-associated AIDS cases. Mexico prohibited the blood trade in 1987, ending the epidemic in paid donors and recipients. latrogenic infection of paid donors in plasmapheresis facilities could help to explain the explosive AIDS epidemic in central Africa and Haiti in the 1980s. There is a temporal and geographical coincidence in the early eighties between that AIDS epidemic, high numbers of hepatitis B asymptomatic carriers and an increased production of serum inactivated hepatitis B vaccine. Plasmapheresis facilities in these developing countries may have taken advantage of the high prevalence of hepatitis B asymptomatic carriers in their populations to obtain plasma for exportation through brokers to developed countries where the vaccine and other plasma products were manufactured. This hypothesis is relevant to establishing preventive policies and warrants further investigation.

Some AIDS physicians are now turning to passive hyperimmune therapy as an alternative to try to protect and rebuild AIDS patients' ravaged immune systems. This is a labor-intensive and expensive treatment that raises many questions.

In Germany, plasmapheresis is carried out for many years in a "mixed" system by private and non-profit organisation. Most of the institutions and blood transfusion service, active in the field of plasmapheresis are members of the "Association for the Establishment, Co-ordination and Working Methods of the Plasmapheresis Centres". All centres are authorized by governmental bodies for manufacturing of pharmaceutical products with regulatory controls regarding licensing and accreditation of blood collection establishment. All parties concerned agree that self-sufficiency of plasma has to be achieved. For this purpose there is a shortage of about 400,000 1 of plasma. In 1994, about 240,000 1 of plasma were collected by plasmapheresis, 91% for fractionation and 8.7% for direct clinical uses. In addition about 970,000 1 of plasma were derived from whole blood donations. The dualism of non-profit making and commercial organisations should be regarded as a chance for diversification in the collection and processing of plasma. A long term increase in plasmapheresis plasma can be achieved by initiating plasmapheresis programmes and co-operation using the existing infrastructures and supports the aim for self-sufficiency.

In Italy, under current legislation, blood collection and productive plasmapheresis are managed by the National Health Service, either directly or indirectly. Donation is voluntary and unpaid. The promotion of donation is addressed to the whole of the population and the organization of periodical donors in associations is encouraged. Donor selection aims at guaranteeing the utmost security of both donors and recipients. Selection procedures are specified by law. Private industries fractionate the source plasma into derivatives. The National Blood and Plasma Plan has an objective to reach an availability of 2,280,000 units of whole blood (i.e. 40 units/1,000 inhabitants) and of 800,000 1 of plasma/annum. At present, whole blood collection covers over 80% of national needs, while plasma production satisfies over 60% of national needs. Self sufficiency in blood and plasma has not so far been achieved. In 1994 the amount of apheresis plasma covers 30% of the amount necessary to achieve self sufficiency. In Italy the technology for plasma collection by apheresis is already adequate in order to reach the above-mentioned objective. On the other hand, in order to reach self-sufficiency, the number of donors undergoing apheresis procedures seems completely insufficient, thus indicating that the priority objective should be the recruitment of new plasma donors.

According to French law, the collection of blood and the separation of plasma by apheresis may only be carried out in ETS licensed by the AFS. The major objective of the recent law is to reinforce and control the safety of blood transfusion and drugs. Plasma donation is based on ethical principles of anonymity, non remuneration and voluntary agreement of the donor. In 1994, the plasma requirements for fractionation were satisfied, with plasmapheresis covering 28%. Since fractionation of French plasma is performed solely by the LFB, the evolution of the use of immunopurified factor VIII will govern future plasmapheresis activity. The number of plasmapheresis donors could potentially be increased in this country, especially if immunopurified factor VIII can be prepared under licence by the LFB. Thus collaboration between public and private industry will be essential to enable France in the future: i) to produce immunopurified factor VIII from plasma collected in the ETS instead of importing the same product prepared abroad from foreign plasma, ii) to contribute to European self-sufficiency and iii) to develop the collection by plasmapheresis of specific plasma for the production of specific immunoglobulins.

Recently it was found that plasmapheresis and intravenous immunoglobulins are effective in treating patients with Guillain-Barré syndrome (GBS). However, these treatments are expensive and not without possible adverse effects. Because signs and symptoms predictive for respiratory failure in GBS would be helpful in targeting the treatment, risk factors for respiratory failure were evaluated in 120 children with GBS. Twenty children required assisted ventilation. None of the children without any of the following risk factors had respiratory failure. If the symptoms of GBS began within 8 days after a preceding infection, the odds ratio (OR) for respiratory failure was 4.9 [95% confidence intervals (CI): 1.3-18.5]. Cranial nerve involvement was more common in children who required assisted ventilation (15/20 versus 32/100, OR: 6.4, 95% CI: 2.1-19.1). A cerebrospinal protein level > 800 mg/L during the first week had an OR for assisted ventilation of 3.1 (95% CI of OR: 1.04-9.0). In the logistic multivariate model, all of these risk factors were associated with the need for assisted ventilation. On the basis of our findings, preventive treatment with either plasmapheresis or intravenous immunoglobulins could be directed to those children with any of the risk factors; for those patients without the risk factors, clinical monitoring would be satisfactory.

The sale of plasma for profit has become a common occurrence. In the United States, a healthy individual can donate as frequently as six times per month and up to 60 L of plasma per year. Although plasma donors are generally healthy, intervening conditions can increase the catabolism or decrease the synthesis of certain serum constituents and thereby produce a confusing clinical picture. In 1 month, we encountered two patients who presented with hypoalbuminemia and hypocholesterolemia for which there was no obvious cause except a history of frequent plasma sales.

Autologous preoperative plasmapheresis which is being performed at the University Hospital of Tübingen since 1984 in advance of surgical, orthopaedic or gynecologic operations, constitutes, in combination with intraoperative autotransfusion (IAT), an optimal method to compensate high losses of intravascular volume. Unlike all other procedures which also substitute lost volume (such as infusion of electrolytic solutions or plasma expanders, haemodilution, retransfusion of preoperatively donated autologous blood, transfusion of homologous plasma or foreign blood) this method grants optimal clotting as well as intravascular retention of volume and in addition to this excludes every risk of infection. Although the therapeutic advantages of autologous preoperative plasmapheresis are well known and confirmed by our statistics (about 75% of the patients do not need any foreign blood), the method is rarely practiced in Germany and mainly performed in specialized hospitals (e.g. in the orthopaedic departments of Tübingen, Ulm, Hamburg, Hannover or Essen). This unfortunate situation is obviously due to some of the following, primarily logistic problems. First of all the procedure of autologous preoperative plasmapheresis needs relatively long planning in advance of the operation (between 2 and 4 weeks) and a number of surgeons renounces the method--even if the patient's medical condition is appropriate and no higher costs are to be expected. The above mentioned alternatives of compensating blood losses are preferred, even if they are in no way comparable in their efficiency. Secondly, in Germany autologous preoperative plasmapheresis is mostly performed by an anaesthetist, who is, however, under our laws obliged to reinfuse the plasma himself, which he has taken from a patient.(ABSTRACT TRUNCATED AT 250 WORDS)

For mixed apheresis procedures {plasma (PMA) and platelets (PLTs) as products}, six cost-accounting methods are described for apportioning the unit procedure cost ($156.02; representative example) to the two products. The methods are derived from clinical/scientific apheresis principles, but provide a wide range of unit PLT costs ($14.10, 19.71, 34.37, 42.06, 43.82 and 52.00) which relate inversely to the corresponding unit PMA costs ($73.84, 63.01, 34.36, 19.37, 15.94 and 0.00). Two of the methods appear particularly appropriate, depending upon whether the procedure is driven by PLTs predominantly or by PMA+PLTs equally. The paper encourages apheresis physicians and scientists to debate the relative attributes of the methods, develop refinements of the same, and determine through dialogue that mixed apheresis costing models properly account for the clinical science of the service provided.

Eight children with Guillain-Barré syndrome were treated with plasmapheresis. Retrospective comparisons were made with 11 historic control patients. Eight children required mechanical ventilation, 4 of whom were in the plasmapheresis group. One week after the last plasmapheresis treatment, patients receiving plasmapheresis within 7 days of symptom onset had improved by one Guillain-Barré syndrome score. Discharge Guillain-Barré syndrome scores were significantly lower for those receiving plasmapheresis (P < .05). Patients in the plasmapheresis group had a decrease in the number of days of mechanical ventilation, time until motor recovery, and overall cost. Our results are consistent with published literature and indicate that plasmapheresis for childhood Guillain-Barré syndrome is a safe and effective treatment to shorten the time to recovery.

The collection of plasma for further manufacture into medicinal products and in vitro diagnostic reagents is predominantly accomplished in the USA through the remuneration of donors who participate in plasmapheresis programmes. A well regulated system under the control of the Food and Drug Administration has been in place since the mid-1970s. Requirements of this regulatory system with regard to the need for donor acceptance and frequency of participation criteria, and plasma acceptability standards are reviewed. Information regarding several groups of donors participating in plasmapheresis procedures at various frequency intervals over 10 years is presented. Data on microhaematocrit, body weight, total protein, and individual serum protein distribution have been compiled and statistically analysed; the results of these analyses are included. Given the existence of a comprehensive approach which encompasses donor safety, plasma testing, and effective manufacturing procedures, safe and efficacious plasma derivatives can be produced from plasma drawn from remunerated donors and can be made available in sufficient quantity to meet medical needs in an economic manner.

Objective: To evaluate the efficacy of high-dose intravenous gammaglobulin (IGIV) versus plasmapheresis in patients with severe Guillain-Barré syndrome (GBS) and compare the costs of both treatments., Design: Retrospective review of all severely disabled GBS patients admitted between January 1 and December 31, 1990., Setting: Neurologic unit of a tertiary-care center., Patients: Six patients fulfilling the criteria for the diagnosis of GBS agreed upon by the ad hoc National Institute of Neurological and Communicative Disorders and Stroke committee., Intervention: Four patients treated with plasmapheresis underwent three to six sessions of plasma exchange. Two patients received IGIV 0.4 g/kg/d administered over a five-day period., Main Outcome Measures: Recovery time, functional assessment (performed according to the grading scale used in the North American trial) at 30, 60, and 90 days after treatment. Cost of plasmapheresis, IGIV, and bed/day were compared., Results: Clinical recovery appeared to be faster and more complete in the IGIV group than in the plasmapheresis group. No adverse reactions related to IGIV treatment appeared. The total cost was greater in the plasmapheresis group., Conclusions: These preliminary results suggest that IGIV may be more beneficial and less expensive than plasmapheresis in treatment of GBS. Definitive conclusions regarding the efficacy of IGIV in GBS will need to await the final analysis of the Ducht randomized multicenter trial comparing IGIV with plasmapheresis.

Acute thrombotic thrombocytopenic purpura (TTP) is a rare and serious disease. Treatment with prednisone, anticoagulation, antiplatelet drugs, splenectomy, exchange transfusions, vincristine, and plasmapheresis may be effective in some patients, but the response to these therapies is inconsistent and all carry the potential for serious side effects. We, and others, have recently seen dramatic responses to intravenous (IV) immunoglobulin G (IgG) when other treatments have failed. Although IV IgG is expensive, its costs are low compared with those extended plasmapheresis regimens. Since the response to treatment can usually be evaluated within a few days and the side effects appear less than with other treatments, we believe a strong case can be made for the use of IV IgG as first-line therapy for acute TTP. Continued multicenter studies are necessary to finally solve the problem of competing and confusing treatment attempts and synergism of treatment in acute TTP.

To determine the cost of expanding blood product operations, the concept of marginal cost must be used. This article reports the development and implementation of a method of costing increases in collecting plasma using apheresis operations. The model takes into account the fact that certain resource inputs--notably, direct labor and machines--increase in discrete steps rather than in a continuous manner. To address this fact, a stepwise cost analysis function was developed, which related operating costs to the volume of apheresis collections. This function was used to predict the marginal costs of potential increases in the supply of plasma at a blood center in Canada. Differences were noted in the cost of plasma in Canada and the United States, much of which could be attributed to different standards regarding the volume of plasma per collection and to differences in pricing materials.

The practice of multiple use of membrane plasmafilters was examined in six patients receiving intermittent or regular plasmapheresis treatment. The plasmafilters were cleaned by flushing and ultrafiltration using positive pressure in the blood and filtrate compartments of the plasmafilter. Twenty-six plasmafilters were studied and the membrane permeability characteristics were examined during 56 plasmapheresis treatments with reused plasmafilters. The clearances of nitrogen urea and creatinine, and the sieving coefficients of albumin and immunoglobulins remained unchanged with the reuse of plasmafilters. The practice is safe, efficient, and can contribute to cost containment in plasmapheresis treatment.

The Asahi Plasmaflo Hollow Nylon Fibre Filtration System (n = 13) was directly compared to the NCI-IBM 2990 Continuous-Flow Blood Fraction Separator (n = 10) for plasma exchange. The systems were equally efficient in achieving plasma separation. There were significant differences favouring filtration for clearance of fibrinogen (P less than 0.05), and the fourth component of complement (P less than 0.01). Greater loss of urea (P less than 0.05) was found after plasma exchange, using the cell separator. The flow characteristics were markedly different. In a standardised 4-L plasma exchange, filtration took place at 35 ml/minute, with a procedure time of 109 +/- 45 minutes in contrast to centrifugation at a plasma flow collection rate of 19 ml/minute, requiring 208 +/- 17 minutes. This time advantage for the former procedure was offset by 195 minutes required to regenerate the hollow nylon fibre unit and a further 90 minutes required for cleaning under strictly controlled aseptic techniques prior to reuse. Each filter was regenerated at least twice and reused without infection, but there was incremental loss of filtration efficiency demonstrated by decreasing clearance of an intravascular marker dye. In two of the 13 procedures using the Plasmaflo system, serious reactions necessitated termination of the procedure; this did not occur using the cell separator. Restriction of the number of times that the filter unit could be regenerated without loss of efficiency, the prolonged time required for regeneration and cleaning, coupled with the need for artificial vascular access to meet high blood flow rates required, limit the usefulness of this technique for plasma exchange.

In a study of 1,551 hemophiliacs over a 4-year period of time, factor VIII utilization was assessed. It is clear that factor VIII usage is a function of severity of disease and therapeutic program. The average amount of factor VIII used per patient was 39,880 U/year. Patients selected for home care, use significantly more than those patients not on home care. As much as 101,000 U/year are used by a small number of patients on prophylaxis. These data can be used in predicting source plasma requirements for annual national use as well as costs.

In a routine donor center, a program of hollow-fiber filtration can be instituted. With the Organon Teknika PLASMAPUR system the collection of 600 ml plasma was completed within 50 min in 76% of the procedures. Changing the tubing set took 12-15 min. From the plasma a frozen cryoprecipitate is made with a recovery of 59%. After pooling, lyophilization and heat treatment, the recovery is 42%.

The principal differences of the USA plasmapheresis collection system from most other countries are: it is conducted by the pharmaceutical industry rather than government, it uses remunerated donors, and it draws a larger volume of plasma than is permitted elsewhere. The implications of these features are reviewed in terms of the effects on donors and the effects on the plasma supply. Protein metabolism is reviewed, and the effects of plasmapheresis on overall nitrogen balance are presented.