1. Efficacy of fibrinogen concentrate in major abdominal surgery – A prospective, randomized, controlled study in cytoreductive surgery for pseudomyxoma peritonei
- Author
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Nigel Sargant, Sanjeev Dayal, Sigurd Knaub, Sophia Stanford, Irina Kruzhkova, Savita Rangarajan, Sean Nunn, Alexios Tzivanakis, Sue Alves, Emily Arbuthnot Smith, Faheez Mohamed, Ashok Roy, Tom Cecil, John Bell, Cristina Solomon, and Brendan Moran
- Subjects
medicine.medical_specialty ,030204 cardiovascular system & hematology ,Fibrinogen ,Hemostatics ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Medicine ,Pseudomyxoma peritonei ,Humans ,Prospective Studies ,Peritoneal Neoplasms ,business.industry ,HAEMOSTASIS ,Hematology ,Original Articles ,Cytoreduction Surgical Procedures ,medicine.disease ,Factor XIII ,Pseudomyxoma Peritonei ,Surgery ,thrombelastography ,Hemostasis ,Cryoprecipitate ,hemostasis ,Hyperthermic intraperitoneal chemotherapy ,Original Article ,business ,cytoreductive surgical procedures ,Abdominal surgery ,medicine.drug - Abstract
Background Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy for pseudomyxoma peritonei (PMP) is associated with excessive bleeding and acquired fibrinogen deficiency. Maintaining plasma fibrinogen may support hemostasis. Objectives To compare hemostatic efficacy and safety of human fibrinogen concentrate (HFC) vs cryoprecipitate as fibrinogen sources for bleeding patients with acquired fibrinogen deficiency undergoing PMP CRS. Methods FORMA‐05 was an off‐label single‐center, prospective, randomized, controlled phase 2 study. Patients undergoing PMP surgery with predicted intraoperative blood loss ≥2 L received human fibrinogen concentrate (HFC; 4 g) or cryoprecipitate (two pools of 5 units, containing approximately 4.0‐4.6 g fibrinogen), repeated as needed. The primary endpoint was a composite of intraoperative and postoperative efficacy, graded using objective 4‐point scales and adjudicated by an independent committee. Results One hundred percent of patients receiving HFC (95% confidence interval: 83.9‐100.0, n = 21) or cryoprecipitate (84.6‐100.0, n = 22) achieved hemostatic success. HFC demonstrated noninferior efficacy (P = .0095; post hoc) and arrived in the operating room 46 minutes faster. There were significantly greater mean increases with HFC vs cryoprecipitate in plasma fibrinogen (0.78 vs 0.35 g/L; P
- Published
- 2019