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Hypofibrinogenemia; Acquired clinical trials

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NCT ID: NCT03444324 Completed - Bleeding Disorder Clinical Trials

Adjusted Fibrinogen Replacement Strategy

AdFIrst
Start date: February 12, 2018
Phase: Phase 3
Study type: Interventional

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.