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Phase 3 trial of fibrinogen concentrate for bleeding during complex cardiac surgery with cardiopulmonary bypass

2024-512388-29-00Phase 3Authorised

Sponsor
LFB Group
Start
Nov 2022
Modality
Recombinant Proteins and Enzymes
Countries
8
01

Overview

Phase 3, randomised, double-blind trial in perioperative bleeding and Bleeding comparing FGTW fibrinogen concentrate with Placebo (2 arms). Primary endpoint: Number of allogeneic blood product and fibrinogen-containing rescue therapy units within 24 hours. Planned start Nov 2022; status: authorised.

02

Drugs

Fibrinogen human
03

Conditions

perioperative bleedingBleeding

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