Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness

EDIPORE

Fibrinogen concentrate is produced by different manufacturers using different purification technologies. The products available in Italy are three: RiaSTAP (CSL Behring), FIBRYGA (Octapharma), and FibCLOT (LFB). RiaSTAP and FIBRYGA are sold in 1-gram vials, and FibCLOT - in 1.5-gram vials. A recent in vitro study assessed how these products affected the clot firmness measured by the ROTEM FIBTEM maximum clot firmness (MCF) parameter. In vitro conditions, FibCLOT was verified to be the most efficient in increasing clot firmness. The present study is aimed to assess, in a series of patients undergoing cardiac surgery with cardiopulmonary bypass, the hypothesis that the FibCLOT fibrinogen is superior to the RiaSTAP fibrinogen in increasing the FIBTEM MCF parameter in a clinical model of bleeding (postoperative bleeding after complex cardiac surgery).

2023-03-20

2024-02-06

2024-02-06

Completed

Early phase I

40

Inclusion Criteria: * elective cardiac surgery with cardiopulmonary bypass; * complex cardiac surgery (coronary artery bypass graft + valve repair/replacement; double/triple valve repair/replacement; ascendant aorta surgery); * written consent to participate; Exclusion Criteria: * urgent or emergent cardiac surgery; * known hypersensitivity to the active principle or to one of the excipients of the study drugs; * coagulation disorders, known or presumable from anamnesis; * known hepatopathy; * known risk of thrombosis or disseminated intravascular coagulation; * participation in another clinical study where an experimental product has been administered within 30 days from the day of the inclusion in the study; * whatever clinical condition that, in the opinion of the investigator, makes the patients not suitable to the experimentation.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, double-blind, randomized', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'A computerized system generated a randomization sequence, and then sealed envelopes containing the drug assigned was prepared. The randomization ratio of the treatment arms was 1:1. An unblinded biologist (E.B.) was in charge of running the ROTEM® tests, randomization, drug preparation, and masking, and its delivery to the operating room. The attending anesthesiologist, the surgical staff, and the medical staff in the ICU and ward were blinded.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

2024-02-28