The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired hypofibrinogenemia. This non-inferiority study focused on the primary objective of demonstrating that BT524 is non-inferior that means not worse than the comparator fresh frozen plasma/cryoprecipitate in reducing intraoperative blood loss when administered intravenously in subjects with acquired hypofibrinogenemia undergoing elective major spinal or abdominal surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent
✓. Subjects scheduled for elective major spinal surgery or cytoreductive pseudomyxoma peritonei (PMP) 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
✓. Subjects who underwent spinal surgery: Intra-operative clinically relevant bleeding of approximately 1 Liter, requiring hemostatic treatment during surgery.
✓. Subjects who underwent cytoreductive PMP surgery: Intra-operative prediction of clinically relevant bleeding of more than 2 Liter, requiring hemostatic treatment during surgery
Exclusion criteria
✕. Pregnancy or unreliable contraceptive measures or breast feeding (women only)
✕. Hypersensitivity to proteins of human origin or known hypersensitivity reactions to components of the Investigational Medicinal Products (IMP)
✕
What they're measuring
1
Intra-operative Blood Loss
Timeframe: From decision to treat the subject with IMP until end of surgery, an average of 5 hours
. Participation in another clinical study within 30 days before entering the study or during the study and/or previous participation in this study
✕. Treatment with any fibrinogen concentrate and/or fibrinogen-containing product within 30 days prior to infusion of IMP
✕. Employee or direct relative of an employee of the Contract Research Organization (CRO), the study site, or Biotest
✕. Inability or lacking motivation to participate in the study
✕. Medical condition, laboratory finding (e.g., clinically relevant biochemical or hematological findings outside the normal range), or physical exam finding that in the opinion of the investigator precludes participation
✕. Presence or history of venous/arterial thrombosis or thromboembolic event (TEE) in the preceding 6 months