MedTrace Logo

Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness

NCT05780125 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-28

No results posted yet for this study

Summary

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).

Conditions

  • Hypofibrinogenemia
  • Surgical Blood Loss
  • Bleeding
  • Cardiac Disease
  • Surgery

Interventions

DRUG

FibCLOT

30 mg/kg of FibCLOT (rounded up to the nearest 2 or 3 grams) after protamine administration

DRUG

RiaSTAP

30 mg/kg of RiaSTAP (rounded up to the nearest 2 or 3 grams) after protamine administration

Sponsors & Collaborators

  • IRCCS Policlinico S. Donato

    lead OTHER

Principal Investigators

  • Marco Ranucci, MD · IRCCS Policlinico S. Donato

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2024-02-06
Completion
2024-02-06

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05780125 on ClinicalTrials.gov