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2. Hemorrhagic shock and tissue injury provoke distinct components of trauma-induced coagulopathy in a swine model

Author

Cralley, Alexis L., Moore, Ernest E., Coleman, Julia R., Vigneshwar, Navin, Bartley, Matt, Kissau, Daniel, Eitel, Andrew, Hom, Patrick, Mitra, Sanchayita, Ghasabyan, Arsen, Fragoso, Miguel, Guo, Zihan, Deguchi, Hiroshi, Griffin, John H., Cohen, Mitchell J., Silliman, Christopher C., Banerjee, Anirban, Hansen, Kirk, and Sauaia, Angela

Published
2023
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6. Succinate Activation of SUCNR1 Predisposes Severely Injured Patients to Neutrophil-mediated ARDS

Author

Nunns, Geoffrey R., Vigneshwar, Navin, Kelher, Marguerite R., Stettler, Gregory R., Gera, Lajos, Reisz, Julie A., D’Alessandro, Angelo, Ryon, Joshua, Hansen, Kirk C., Gamboni, Fabia, Moore, Ernest E., Peltz, Erik D., Cohen, Mitchell J., Jones, Kenneth L., Sauaia, Angela, Liang, Xiayuan, Banerjee, Anirban, Ghasabyan, Arsen, Chandler, James G., Rodawig, Sophia, Jones, Carter, Eitel, Andrew, Hom, Patrick, and Silliman, Christopher C.

Published
2022
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8. STudy of Alteplase for Respiratory failure in SARS-Cov2 COVID-19 (STARS): A Vanguard Multicenter, Rapidly Adaptive, Pragmatic, Randomized, Controlled Trial

Author

Barrett, Christopher D., Moore, Hunter B., Moore, Ernest E., Wang, D. Janice, Hajizadeh, Negin, Biffl, Walter L., Lottenberg, Lawrence, Patel, Purvesh R., Truitt, Michael S., McIntyre, Robert, Bull, Todd M., Ammons, Lee Anne, Ghasabyan, Arsen, Chandler, James, Douglas, Ivor, Schmidt, Eric, Moore, Peter K., Wright, Franklin L., Ramdeo, Ramona, Borrego, Robert, Rueda, Mario, Dhupa, Achal, McCaul, D. Scott, Dandan, Tala, Sarkar, Pralay K., Khan, Benazir, Sreevidya, Coimbatore, McDaniel, Conner, Grossman Verner, Heather M., Pearcy, Christopher, Anez-Bustillos, Lorenzo, Baedorf-Kassis, Elias N., Jhunjhunwala, Rashi, Shaefi, Shahzad, Capers, Krystal, Banner-Goodspeed, Valerie, Talmor, Daniel S., Sauaia, Angela, and Yaffe, Michael B.

Published
2021
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9. Trauma Resuscitation Consideration: Sex Matters

Author

Coleman, Julia R., Moore, Ernest E., Samuels, Jason M., Cohen, Mitchell J., Sauaia, Angela, Sumislawski, Joshua J., Ghasabyan, Arsen, Chandler, James G., Banerjee, Anirban, Silliman, Christopher C., and Peltz, Erik D.

Published
2019
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18. Study of Alteplase for Respiratory Failure in SARS-CoV-2 COVID-19: A Vanguard Multicenter, Rapidly Adaptive, Pragmatic, Randomized Controlled Trial.

Author

Barrett, Christopher D., Moore, Hunter B., Moore, Ernest E., Wang, Janice, Hajizadeh, Negin, Biffl, Walter L., Lottenberg, Lawrence, Patel, Purvesh R., Truitt, Michael S., McIntyre, Robert C., Bull, Todd M., Ammons, Lee Anne, Ghasabyan, Arsen, Chandler, James, Douglas, Ivor S., Schmidt, Eric P., Moore, Peter K., Wright, Franklin L., Ramdeo, Ramona, and Borrego, Robert

Subjects
RESPIRATORY insufficiency, TISSUE plasminogen activator, COVID-19, SARS-CoV-2, ALTEPLASE, BRAIN imaging
Abstract

Background: Pulmonary vascular microthrombi are a proposed mechanism of COVID-19 respiratory failure. We hypothesized that early administration of tissue plasminogen activator (tPA) followed by therapeutic heparin would improve pulmonary function in these patients.Research Question: Does tPA improve pulmonary function in severe COVID-19 respiratory failure, and is it safe?Study Design and Methods: Adults with COVID-19-induced respiratory failure were randomized from May14, 2020 through March 3, 2021, in two phases. Phase 1 (n = 36) comprised a control group (standard-of-care treatment) vs a tPA bolus (50-mg tPA IV bolus followed by 7 days of heparin; goal activated partial thromboplastin time [aPTT], 60-80 s) group. Phase 2 (n = 14) comprised a control group vs a tPA drip (50-mg tPA IV bolus, followed by tPA drip 2 mg/h plus heparin 500 units/h over 24 h, then heparin to maintain aPTT of 60-80 s for 7 days) group. Patients were excluded from enrollment if they had not undergone a neurologic examination or cross-sectional brain imaging within the previous 4.5 h to rule out stroke and potential for hemorrhagic conversion. The primary outcome was Pao2 to Fio2 ratio improvement from baseline at 48 h after randomization. Secondary outcomes included Pao2 to Fio2 ratio improvement of > 50% or Pao2 to Fio2 ratio of ≥ 200 at 48 h (composite outcome), ventilator-free days (VFD), and mortality.Results: Fifty patients were randomized: 17 in the control group and 19 in the tPA bolus group in phase 1 and eight in the control group and six in the tPA drip group in phase 2. No severe bleeding events occurred. In the tPA bolus group, the Pao2 to Fio2 ratio values were significantly (P < .017) higher than baseline at 6 through 168 h after randomization; the control group showed no significant improvements. Among patients receiving a tPA bolus, the percent change of Pao2 to Fio2 ratio at 48 h (16.9% control [interquartile range (IQR), -8.3% to 36.8%] vs 29.8% tPA bolus [IQR, 4.5%-88.7%]; P = .11), the composite outcome (11.8% vs 47.4%; P = .03), VFD (0.0 [IQR, 0.0-9.0] vs 12.0 [IQR, 0.0-19.0]; P = .11), and in-hospital mortality (41.2% vs 21.1%; P = .19) did not reach statistically significant differences when compared with those of control participants. The patients who received a tPA drip did not experience benefit.Interpretation: The combination of tPA bolus plus heparin is safe in severe COVID-19 respiratory failure. A phase 3 study is warranted given the improvements in oxygenation and promising observations in VFD and mortality.Trial Registry: ClinicalTrials.gov; No.: NCT04357730; URL: www.clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

Published
2022
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24. All animals are equal but some animals are more equal than others: Plasma lactate and succinate in hemorrhagic shock-A comparison in rodents, swine, nonhuman primates, and injured patients.

Author

Reisz, Julie A., Wither, Matthew J., Moore, Ernest E., Slaughter, Anne L., Moore, Hunter B., Ghasabyan, Arsen, Chandler, James, Schaub, Leasha J., Fragoso, Miguel, Nunns, Geoffrey, Silliman, Christopher C., Hansen, Kirk C., Banerjee, Anirban, Sheppard, Forest R., and D'Alessandro, Angelo

Published
2018
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27. Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy.

Author

Gonzalez, Eduardo, Moore, Ernest E., Moore, Hunter B., Chapman, Michael P., Chin, Theresa L., Ghasabyan, Arsen, Wohlauer, Max V., Barnett, Carlton C., Bensard, Denis D., Biffl, Walter L., Burlew, Clay C., Johnson, Jeffrey L., Pieracci, Fredric M., Jurkovich, Gregory J., Banerjee, Anirban, Silliman, Christopher C., and Sauaia, Angela

Abstract

Background: Massive transfusion protocols (MTPs) have become standard of care in the management of bleeding injured patients, yet strategies to guide them vary widely.We conducted a pragmatic, randomized clinical trial (RCT) to test the hypothesis that an MTP goal directed by the viscoelastic assay thrombelastography (TEG) improves survival compared with an MTP guided by conventional coagulation assays (CCA). Methods: This RCT enrolled injured patients from an academic level-1 trauma center meeting criteria for MTP activation. Upon MTP activation, patients were randomized to be managed either by an MTP goal directed by TEG or by CCA (ie, international normalized ratio, fibrinogen, platelet count). Primary outcome was 28-day survival. Results: One hundred eleven patients were included in an intent-to-treat analysis (TEG = 56, CCA = 55). Survival in the TEG group was significantly higher than the CCA group (log-rank P = 0.032, Wilcoxon P = 0.027); 20 deaths in the CCA group (36.4%) compared with 11 in the TEG group (19.6%) (P = 0.049). Most deaths occurred within the first 6 hours from arrival (21.8% CCA group vs 7.1% TEG group) (P = 0.032). CCA patients required similar number of red blood cell units as the TEG patients [CCA: 5.0 (2-11), TEG: 4.5 (2-8)] (P=0.317), but more plasma units [CCA: 2.0 (0-4), TEG: 0.0 (0-3)] (P = 0.022), and more platelets units [CCA: 0.0 (0-1), TEG: 0.0 (0-0)] (P = 0.041) in the first 2 hours of resuscitation. Conclusions: Utilization of a goal-directed, TEG-guided MTP to resuscitate severely injured patients improves survival compared with an MTP guided by CCA and utilizes less plasma and platelet transfusions during the early phase of resuscitation. [ABSTRACT FROM AUTHOR]

Published
2016
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35. Association of Prehospital Plasma Transfusion With Survival in Trauma Patients With Hemorrhagic Shock When Transport Times Are Longer Than 20 Minutes: A Post Hoc Analysis of the PAMPer and COMBAT Clinical Trials.

Author

Pusateri, Anthony E., Moore, Ernest E., Moore, Hunter B., Le, Tuan D., Guyette, Francis X., Chapman, Michael P., Sauaia, Angela, Ghasabyan, Arsen, Chandler, James, McVaney, Kevin, Brown, Joshua B., Daley, Brian J., Miller, Richard S., Harbrecht, Brian G., Claridge, Jeffrey A., Phelan, Herb A., Witham, William R., Putnam, A. Tyler, and Sperry, Jason L.

Published
2020
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36. Plasma-first resuscitation to treat haemorrhagic shock during emergency ground transportation in an urban area: a randomised trial.

Author

Moore, Hunter B., Moore, Ernest E., Chapman, Michael P., McVaney, Kevin, Bryskiewicz, Gary, Blechar, Robert, Chin, Theresa, Burlew, Clay Cothren, Pieracci, Fredric, West, F. Bernadette, Fleming, Courtney D., Ghasabyan, Arsen, Chandler, James, Silliman, Christopher C., Banerjee, Anirban, and Sauaia, Angela

Subjects
*RESUSCITATION, *BLOOD plasma, *HEMORRHAGIC shock treatment, *RANDOMIZED controlled trials, *MEDICAL emergencies, *AMBULANCES, *COMPARATIVE studies, *EMERGENCY medical services, *HEMORRHAGIC shock, *RESEARCH methodology, *MEDICAL cooperation, *RESEARCH, *SALT, *STATISTICAL sampling, *SURVIVAL, *TRAUMA centers, *EVALUATION research
Abstract

Background: Plasma is integral to haemostatic resuscitation after injury, but the timing of administration remains controversial. Anticipating approval of lyophilised plasma by the US Food and Drug Administration, the US Department of Defense funded trials of prehospital plasma resuscitation. We investigated use of prehospital plasma during rapid ground rescue of patients with haemorrhagic shock before arrival at an urban level 1 trauma centre.Methods: The Control of Major Bleeding After Trauma Trial was a pragmatic, randomised, single-centre trial done at the Denver Health Medical Center (DHMC), which houses the paramedic division for Denver city. Consecutive trauma patients in haemorrhagic shock (defined as systolic blood pressure [SBP] ≤70 mm Hg or 71-90 mm Hg plus heart rate ≥108 beats per min) were assessed for eligibility at the scene of the injury by trained paramedics. Eligible patients were randomly assigned to receive plasma or normal saline (control). Randomisation was achieved by preloading all ambulances with sealed coolers at the start of each shift. Coolers were randomly assigned to groups 1:1 in blocks of 20 according to a schedule generated by the research coordinators. If the coolers contained two units of frozen plasma, they were defrosted in the ambulance and the infusion started. If the coolers contained a dummy load of frozen water, this indicated allocation to the control group and saline was infused. The primary endpoint was mortality within 28 days of injury. Analyses were done in the as-treated population and by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01838863.Findings: From April 1, 2014, to March 31, 2017, paramedics randomly assigned 144 patients to study groups. The as-treated analysis included 125 eligible patients, 65 received plasma and 60 received saline. Median age was 33 years (IQR 25-47) and median New Injury Severity Score was 27 (10-38). 70 (56%) patients required blood transfusions within 6 h of injury. The groups were similar at baseline and had similar transport times (plasma group median 19 min [IQR 16-23] vs control 16 min [14-22]). The groups did not differ in mortality at 28 days (15% in the plasma group vs 10% in the control group, p=0·37). In the intention-to-treat analysis, we saw no significant differences between the groups in safety outcomes and adverse events. Due to the consistent lack of differences in the analyses, the study was stopped for futility after 144 of 150 planned enrolments.Interpretation: During rapid ground rescue to an urban level 1 trauma centre, use of prehospital plasma was not associated with survival benefit. Blood products might be beneficial in settings with longer transport times, but the financial burden would not be justified in an urban environment with short distances to mature trauma centres.Funding: US Department of Defense. [ABSTRACT FROM AUTHOR]

Published
2018
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