Novel Treatment Effective for Controlling Bleeding in Patients Undergoing Surgery for Pseudomyxoma Peritonei

March 24, 2019

By Charles Grey

BRUSSELS, Belgium -- March 22, 2019 -- A new, highly purified, double virus-inactivated human fibrinogen concentrate (HFC) was at least as efficacious as cryoprecipitate for the treatment of bleeding in patients undergoing cytoreductive surgery for pseudomyxoma peritonei (PMP), according to a study presented here at the 39th International Symposium on Intensive Care and Emergency Medicine (ISICEM).

Pre-emptive HFC infusion led to a greater mean increase in plasma fibrinogen concentration versus cryoprecipitate (0.72 vs. 0.36 g/L; P = .0038).

Pre-emptive HFC infusion also led to a greater mean increase in the FIBTEM A20 measurement of maximum clot firmness versus cryoprecipitate (3.43 vs 1.05 mm; P = .0088).

Ashok Roy, MD, Basingstoke and North Hampshire Hospital, Hampshire, United Kingdom, and colleagues conducted a prospective, single-centre, randomized controlled phase 2 study in adults with acquired fibrinogen deficiency undergoing cytoreductive surgery for PMP.

The primary endpoint was a composite of intraoperative (assessed by the surgeon/anaesthesiologist) and postoperative (assessed by the haematologist) efficacy, determined using 4-point haemostatic efficacy scales (excellent, good, moderate, none), and adjudic
ated by an Independent Data Monitoring and Endpoint Adjudication Committee (IDMEAC). A total of 45 patients were enrolled, 22 of whom received HFC and 23 of whom received cryoprecipitate.

Intraoperative haemostatic efficacy was rated by the surgeon/anaesthesiologist as excellent or good for 95.2% of patients who received HFC versus 81.8% of patients who received cryoprecipitate; these ratings were adjudicated by the IDMEAC as 95.2% and 72.7%, respectively. The overall postoperative haemostatic efficacy was rated as excellent by both the haematologist and the IDMEAC for all patients in both groups.

Infusions of HFC were administered earlier than cryoprecipitate because of faster product availability.

According to a post hoc analysis, HFC was non-inferior to cryoprecipitate for overall hemostatic efficacy (P = .0095).

No safety concerns, including thromboembolic events, relating to the use of HFC were identified in the study.

[Presentation title: Fibrinogen Concentrate Versus Cryoprecipitate in Pseudomyxoma Peritonei Surgery: Results From a Prospective, Randomised, Controlled Phase 2 Study]