Adjusted Fibrinogen Replacement Strategy (AdFIrst)

This is an interventional treatment trial for Bleeding Disorder focused on measuring Fibrinogen Read More

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 -