Adjusted Fibrinogen Replacement Strategy
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.
Timeline
- Start
- 2018-04-03
- Primary completion
- 2023-09-25
- Completion
- 2023-11-21
Outcome
Met primary endpoint
paper The primary endpoint was met; the least squares mean (LSM: adjusted mean estimated using ANOVA) intraoperative blood loss was 1381 mL PMID 40741224 ↗
registry analysis (non-inferiority test); BT524 vs Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo); p <0.001; Difference in LSM -279.43 (95% CI -552.38 to -6.48) NCT03444324 ↗
release “In the AdFIrst study, Biotest's fibrinogen concentrate (FC), BT524, met the primary endpoint, demonstrating its effectiveness in treating acquired fibrinogen deficiency (AFD)” grifols.com ↗
Publications
- Roy A, Stanford S, Cecil T, Preston N, Rowley J, Porter P, Schimo S, Abraha S, Staus A, Balaban U, Wessels-Kranz J, Schuttrumpf J, Aigner S, Bohm H, Rahe-Meyer N. Efficacy and safety of fibrinogen concentrate (BT524) in severe hemorrhage: Phase 3 subcohort analysis of the AdFIrst trial in patients undergoing cytoreductive surgery for pseudomyxoma peritonei. J Clin Anesth. 2026 Jun 5;113:112242. doi: 10.1016/j.jclinane.2026.112242. Online ahead of print.
- Rahe-Meyer N, Roy A, Trouillier HH, Schimo S, Wessels-Kranz J, Abraha S, Staus A, Balaban U, Hader T, Schuttrumpf J, Aigner S, Bohm H. Efficacy and safety of human fibrinogen concentrate (BT524) in patients with major haemorrhage undergoing major orthopaedic or abdominal surgery (AdFIrst): a randomised, active-controlled, multicentre, partially blinded, phase 3 non-inferiority trial. EClinicalMedicine. 2025 Jun 7;85:103264. doi: 10.1016/j.eclinm.2025.103264. eCollection 2025 Jul.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BT524 | Protein / enzyme biologic | 2 g | Intravenous |
| Subject | BT524 | Protein / enzyme biologic | 4 g | Intravenous |
| Comparator | Cryoprecipitate | Protein / enzyme biologic | 10 unknown | Intravenous |
| Comparator | Fresh Frozen Plasma | Protein / enzyme biologic | 15 ml | Intravenous |