Comparison of coagulation parameters associated with fibrinogen concentrate and cryoprecipitate for treatment of bleeding in patients undergoing cytoreductive surgery for pseudomyxoma peritonei: Subanalysis from a randomized, controlled phase 2 study

• Published in: Health science reports 2023-09, Vol.6 (9), p.e1558-e1558
• Main Authors: Roy, Ashok, Sargant, Nigel, Bell, John, Stanford, Sophia, Solomon, Cristina, Kruzhkova, Irina, Knaub, Sigurd, Mohamed, Faheez
• Format: Article
• Language: English
• Subjects: Abdomen; Asymptomatic; blood coagulation factor; Blood groups; Body mass index; cytoreduction surgical procedures; Epidemiology; fibrinogen; Gastroenterology/Hepatology; General Medicine; Genetics and Genomics; Hematology; hemorrhage; Original Research; Oxygen saturation; Patients; Pharmacology and Pharmacy; Plasma; Proteins; pseudomyxoma peritonei; Pulmonary embolisms; Surgery; Thromboembolism; Thrombosis; Tomography; Tumors; venous thrombosis
• ISSN: 2398-8835; 2398-8835
• DOI: 10.1002/hsr2.1558

What's known Purified human fibrinogen concentrate (HFC) has been used for fibrinogen replacement in acquired bleeding across a number of clinical settings including surgery, trauma and major obstetric hemorrhage. The randomized, controlled, FORMA‐05 study compared efficacy and safety of HFC and cryoprecipitate for hemostasis in surgical bleeding during major abdominal surgery. HFC maintained overall hemostatic efficacy with noninferiority to cryoprecipitate, with coagulation factor levels maintained throughout surgery. What's new This subanalysis of the FORMA‐05 study examined the changes in coagulation parameters during and after surgery in patients receiving HFC versus cryoprecipitate. Seven patients experienced thromboembolic events (TEEs), all of whom were on cryoprecipitate. Of these, two patients had deep vein thromboses (DVT), with higher fibrinogen, FIBTEM A20, and platelet levels, which persisted perioperatively. The five patients who developed pulmonary embolism (PE) had slightly higher preoperative von Willebrand factor (VWF) levels, which increased disproportionately following cryoprecipitate administration and postoperatively. Clinical implications Study results indicated a procoagulant status in patients experiencing DVT, and a disproportionate intra‐ and postoperative increase in VWF for patients experiencing PE. Larger studies in more diverse surgical settings should consider recording coagulation factor levels to gain a better understanding of how coagulation factor levels relate to TEEs.