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

Phase 1

• Conditions: Elective spine 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-BE
• Lead Sponsor: Biotest AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-26
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

At screening:
1.Written informed consent
2.Subjects scheduled for elective major spine 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

Intra-operative:
5.Intra-operative bleeding > 1,000 mL (total blood loss), resulting in a high risk for the need of FFP transfusion during surgery.

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 160
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 lactation period (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