FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research is to understand if the medication called FEIBA helps to stop bleeding and decrease transfusion of blood products to small children operated on the heart.

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

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Anti-inhibitor coagulant complex

Criteria

Inclusion Criteria:

• Weight ≤ 15 kg.

• Elective cardiac surgery with cardiopulmonary bypass.

• Coagulopathic bleeding after cardiopulmonary bypass.

• Availability and willingness of the parent/legal guardian to provide informed consent.

Exclusion Criteria:

• Presence of mechanical circulatory support at the time of randomization or POD 0 and 1.

• Patient or family history of coagulopathy and/or thromboses.

• Preoperative anticoagulation (excluding low dose heparin for "line prophylaxis").