Adjusted Fibrinogen Replacement Strategy (AdFIrst)

  • STATUS
    Recruiting
  • End date
    Mar 26, 2023
  • participants needed
    200
  • sponsor
    Biotest
Updated on 26 April 2022
blood transfusion
fibrinogen
spine surgery

Summary

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.

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).

Details
Condition Bleeding Disorder, Hypofibrinogenemia; Acquired
Treatment BT524, FFP, FFP/Cryo
Clinical Study IdentifierNCT03444324
SponsorBiotest
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

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 -
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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