Adjusted Fibrinogen Replacement Strategy (AdFIrst)

Biotest

Status and phase: Completed; Phase 3

Conditions: Bleeding Disorder; Hypofibrinogenemia; Acquired

Treatments: Biological: FFP/Cryo; Biological: BT524

Study type: Interventional

Funder types: Industry

Identifiers

NCT03444324

995

2017-001163-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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 BT524
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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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222 participants in 2 patient groups

BT524

Experimental group

Description:

Investigational Human Fibrinogen Concentrate

Treatment:

Biological: BT524

Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)

Active Comparator group

Description:

Standard of Care

Treatment:

Biological: FFP/Cryo