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

Ashok Roy; Nigel Sargant; John Bell; Sophia Stanford; Cristina Solomon; Irina Kruzhkova; Sigurd Knaub; Faheez Mohamed

doi:10.1002/hsr2.1558

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

Health Sci Rep. 2023 Sep 26;6(9):e1558. doi: 10.1002/hsr2.1558. eCollection 2023 Sep.

Authors

Ashok Roy¹, Nigel Sargant¹, John Bell¹, Sophia Stanford¹, Cristina Solomon², Irina Kruzhkova², Sigurd Knaub², Faheez Mohamed¹

Affiliations

¹ Peritoneal Malignancy Institute Basingstoke and North Hampshire Hospital Hampshire UK.
² Octapharma AG Lachen Switzerland.

Abstract

Background and aims: The FORMA-05 study compared the efficacy and safety of human fibrinogen concentrate (HFC) versus cryoprecipitate for hemostasis in bleeding patients undergoing cytoreductive surgery for pseudomyxoma peritonei (PMP). This subanalysis explores coagulation parameters in the FORMA-05 patients, with a focus on the seven patients who developed thromboembolic events (TEEs).

Methods: FORMA-05 was a prospective, randomized, controlled phase 2 study in which patients with predicted blood loss ≥2 L received HFC (4 g) or cryoprecipitate (two pools of five units), repeated as needed. Plasma fibrinogen, platelet count, factor (F) XIII, FVIII, von Willebrand Factor (VWF) antigen and ristocetin cofactor activity levels, EXTEM A20, FIBTEM A20, and endogenous thrombin potential (ETP) were measured perioperatively.

Results: Fibrinogen, platelet count, EXTEM and FIBTEM A20, FXIII, FVIII, VWF levels, and ETP were maintained throughout surgery in both the HFC group (N = 21) and the cryoprecipitate group (N = 23). Seven TEEs were observed in the cryoprecipitate group. The two patients developing deep vein thromboses (DVT) appeared to have a procoagulant status preoperatively, with distinctively higher fibrinogen level, FIBTEM A20, and platelet levels, all of which persisted perioperatively. The five patients developing pulmonary embolism (PE) had slightly higher VWF levels preoperatively, with a disproportionate increase intraoperatively (postcryoprecipitate administration) and postoperatively.

Conclusions: Patients treated with HFC versus cryoprecipitate showed broad overlaps in coagulation parameters. Patients with PE experienced a disproportionate VWF rise following cryoprecipitate administration, whereas patients developing DVT displayed a procoagulant status before and following surgery. Preoperative testing may allow these patients to be identified.

Keywords: blood coagulation factor; cytoreduction surgical procedures; fibrinogen; hemorrhage; pseudomyxoma peritonei; venous thrombosis.