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About
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.
Full 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).
Enrollment
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Inclusion criteria
At screening:
Written informed consent
Subjects scheduled for elective major spine surgery with expected major blood loss
Male or female, aged ≥ 18 years
No increased bleeding risk as assessed by standard coagulation tests and medical history
Intra-operative:
Intra-operative bleeding > 1,000 mL (total blood loss), resulting in a high risk for the need of FFP transfusion during surgery.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
222 participants in 2 patient groups
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Central trial contact
Joachim Schütze, PhD; Judith Wessels-Kranz, PhD
Data sourced from clinicaltrials.gov
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