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Adjusted Fibrinogen Replacement Strategy — AdFIrst  

Bleeding Disorder Clinical Trial

Official title:
A Randomized, Active-controlled, Multicenter, Phase III Study Investigating Efficacy and Safety of Intra-operative Use of BT524 (Human Fibrinogen Concentrate) in Subjects Undergoing Major Spinal or Abdominal Surgery (AdFIrst)

Clinical Trial Summary

The purpose of this study is to investigate efficacy and safety of fibrinogen concentrate BT524, when administered to patients with major blood loss during elective spine surgery.The study aims to demonstrate that BT524 is at least not worse than the comparator fresh frozen plasma in reducing intra-operative blood loss.

Clinical Trial Description

Fibrinogen is the first coagulation factor to become critically reduced during intra-operative bleeding. Therefore, rapid fibrinogen supplementation to restore physiological plasma levels is an important component to achieve and maintain hemostasis in bleeding patients. In this study, patients with major blood loss during elective spine surgery will be randomized 1:1 to a single intravenous transfusion of the fibrinogen concentrate BT524 or to fibrinogen-containing fresh frozen plasma (FFP). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03444324
Study type Interventional
Source Biotest
Contact
Status Completed
Phase Phase 3
Start date February 12, 2018
Completion date October 2, 2023
View Details
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