Adjusted Fibrinogen Replacement Strategy

Exclusion Criteria

• •1. Pregnancy or unreliable contraceptive measures or breast feeding (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 IMP
• •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 thromboembolic event (TEE) in the preceding 6 months