Trial | NCT03444324  Report issue

Title

Adjusted Fibrinogen Replacement Strategy
A Randomized, Active-controlled, Multicenter, Phase III Study Investigating Efficacy and Safety of Intra-operative Use of BT524 (Human Fibrinogen Concentrate) in Subjects Undergoing Major Spinal or Abdominal Surgery (AdFIrst)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    222
The purpose of this study is to investigate efficacy and safety of fibrinogen concentrate BT524, when administered to patients with major blood loss during elective spine surgery.The study aims to demonstrate that BT524 is at least not worse than the comparator fresh frozen plasma in reducing intra-operative blood loss.
Fibrinogen is the first coagulation factor to become critically reduced during intra-operative bleeding. Therefore, rapid fibrinogen supplementation to restore physiological plasma levels is an important component to achieve and maintain hemostasis in bleeding patients. In this study, patients with major blood loss during elective spine surgery will be randomized 1:1 to a single intravenous transfusion of the fibrinogen concentrate BT524 or to fibrinogen-containing fresh frozen plasma (FFP).
Study Started
Feb 12
2018
Primary Completion
Sep 25
2023
Study Completion
Oct 02
2023
Last Update
Nov 18
2023

Biological BT524

BT524 is administered intravenously, patient specific dosage calculated based on body weight and fibrinogen level.

  • Other names: Human Fibrinogen concentrate

Biological FFP/Cryo

FFP/Cryo is administered intravenously; dosage according to local standards in mL per kg body weight.

  • Other names: Fresh Frozen Plasma

BT524 Experimental

Investigational Human Fibrinogen Concentrate

Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo) Active Comparator

Standard of Care

Criteria 

Inclusion Criteria:

At screening:

Written informed consent
Subjects scheduled for elective major spine 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:

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

Exclusion Criteria:

Pregnancy or unreliable contraceptive measures or lactation period (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 BT524
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 TEE in the preceding 6 months -
No Results Posted