Status:
COMPLETED
Adjusted Fibrinogen Replacement Strategy
Lead Sponsor:
Biotest
Collaborating Sponsors:
PRA Health Sciences
ICON Clinical Research
Conditions:
Bleeding Disorder
Hypofibrinogenemia; Acquired
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 he...
Detailed Description
Fibrinogen is the first coagulation factor to become critically reduced during intraoperative bleeding. Therefore, rapid supplementation of fibrinogen to restore physiological plasma levels is an impo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2023
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT03444324
Start Date
April 3 2018
End Date
November 21 2023
Last Update
June 13 2025
Active Locations (19)
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1
Site 02
Jette, Belgium
2
Site 01
Leuven, Belgium
3
Site 54
Brno, Czechia
4
Site 51
Prague, Czechia