Phase 3
N=222
Adjusted Fibrinogen Replacement Strategy
Bleeding Disorder · Hypofibrinogenemia; Acquired
Bottom Line
View on ClinicalTrials.gov: NCT03444324 ↗Enrolled (actual)
222
Serious AEs
31.1%
Results posted
Jun 2025
Primary outcome: Primary: Intra-operative Blood Loss — 1380.7; 1660.13 mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BT524 (Biological); FFP/Cryo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biotest
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-operative Blood Loss |
1380.7; 1660.13 | <0.001 sig |
| SECONDARY Proportion (%) of Subjects With Successful Correction of Fibrinogen Level (FIBTEM A10) 15 Minutes After Start of First IMP Administration |
59; 19 | <0.001 sig |
| SECONDARY Time to First Successful Correction of Fibrinogen Level |
59; 19; 17; 11; 11; 16 | <0.001 sig |
| SECONDARY Transfusion Requirements: Cell Salvage |
95.6; 78.0 | — |
| SECONDARY Transfusion Requirements: Allogeneic Platelets |
3.0; 3.6 | — |
| SECONDARY Transfusion Requirements: Allogeneic Red Blood Cells |
455.5; 488.4 | — |
| SECONDARY Transfusion Requirements: Fresh Frozen Plasma |
60.5; 14.8 | — |
| SECONDARY Transfusion Requirements, Cryoprecipitate |
0; 0 | — |
| SECONDARY Amount of Red Blood Cells (RBCs) |
543.4; 558.9 | <0.831 |
| SECONDARY Post-operative Blood Loss |
306.3; 293.9 | =0.809 |
| SECONDARY Subjects With Rebleeds |
0; 5 | =0.022 sig |
| SECONDARY Hospital Length of Stay After Surgery |
7; 4; 4; 10; 13; 12 | — |
| SECONDARY In-hospital Mortality |
0; 0 | — |
| SECONDARY Number of Subjects With Thrombosis or Thromboembolic Events (TEEs) |
8; 13 | — |
| SECONDARY Change in Viral Status |
0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
At screening:
- 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
Intra-operative:
5.
- 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)
- 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
Data sourced from ClinicalTrials.gov (NCT03444324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.