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Adjusted Fibrinogen Replacement Strategy

NCT03444324 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2025-06-13

Study results available
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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.

Conditions

  • Bleeding Disorder
  • Hypofibrinogenemia; Acquired

Interventions

BIOLOGICAL

BT524

BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.

BIOLOGICAL

FFP/Cryo

FFP/Cryo was administered intravenously; dosage according to local standards. FFP, 15 mL per kg body weight (BW); Cryoprecipitate, fixed dose of 10 units.

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • ICON Clinical Research

    collaborator INDUSTRY

  • Biotest

    lead INDUSTRY

Principal Investigators

  • Niels Rahe-Meyer, Prof. · Franziskus Hospital, Bielefeld

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-03
Primary Completion
2023-09-25
Completion
2023-11-21

Countries

  • Belgium
  • Czechia
  • Germany
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03444324 on ClinicalTrials.gov