Haemocomplettan® P During Elective Complex Cardiac Surgery

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy. Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events remains unknown.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isala
• Collaborator: CSL Behring

Criteria

Inclusion Criteria:

• Eighteen years of age or older.

• Undergoing elective complex cardiac surgery.

• Understood and willingly given written informed consent.

• Experience clinically relevant non-surgical microvascular bleeding following removal of cardiopulmonary bypass.

Exclusion Criteria:

• Positive pregnancy test, pregnancy or lactation.

• Undergoing an emergency operation.

• Proof or suspicion of a congenital or acquired coagulation disorder.

• Clopidogrel use in the 5 days preceding surgery.

• INR >1.4 if on coumadin.