Clinical study investigating efficacy and safety of BT524 in intra-operative use in patients undergoing major spinal or abdominal surgery

Phase 1

• Conditions: Elective spinal or abdominal surgery with expected major blood loss; MedDRA version: 20.0Level: PTClassification code 10051125Term: HypofibrinogenaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2017-001163-20-CZ
• Lead Sponsor: Biotest AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-26
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

At screening:
1.Written informed consent
2.Subjects scheduled for elective major spinal or cytoreductive pseudomyxoma peritonei (PMP)* surgery with expected major blood loss
3.Male or female, aged = 18 years
4.No increased bleeding risk as assessed by standard coagulation tests and medical history*
5.Intra-operative trigger for treatment:
a. Subjects undergoing spinal surgery: Intra-operative clinically relevant bleeding of approximately 1L, requiring hemostatic treatment during surgery**
b. Subjects undergoing cytoreductive PMP*surgery : Intra-operative prediction of clinically relevant bleeding of > 2 L, requiring hemostatic treatment during surgery***
*Inclusion criterion no. 4 aims to ensure that only subjects without hereditary bleeding disorders are to be included in this study. Subjects with continuous 'aspirin intake', subjects under Direct Oral Anti-Coagulants (DOACs), or with a hepatic disease are at higher bleeding risk. Nevertheless, these subjects can be included at the discretion of the investigator.
**A clinically relevant bleeding, resulting in a high risk for the need of fibrinogen supplementation with BT524 or FFP during surgery. The amount of clinically relevant blood loss depends on the subject's clinical condition, e.g. underlying disease, significant comorbidities, low body weight, relevant change of a laboratory value.
***Only applicable for subjects in the UK

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Pregnancy or unreliable contraceptive measures or breast feeding (women only)
2.Hypersensitivity to proteins of human origin or known hypersensitivity reactions to components of the Investigational Medicinal Products (IMP)
3.Participation in another clinical study within 30 days before entering the study or during the study and/or previous participation in this study
4.Treatment with any fibrinogen concentrate and/or fibrinogen-containing product within 30 days prior to infusion of IMP
5.Employee or direct relative of an employee of the Contract Research Organization (CRO), the study site, or Biotest
6.Inability or lacking motivation to participate in the study
7.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
8.Presence or history of venous/arterial thrombosis or TEE in the preceding 6 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified