FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients

Mayo Clinic

Status and phase: Withdrawn; Phase 2

Conditions: Cardiac Disease

Treatments: Drug: Placebo; Drug: FEIBA

Study type: Interventional

Funder types: Other

Identifiers

NCT05020483

21-005539

Details and patient eligibility

About

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.

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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").

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

FEIBA Group

Experimental group

Description:

Pediatric patients ≤15 kg of weight, undergoing cardiac surgery with cardiopulmonary bypass will receive activated prothrombin complex concentrate (aPCC) FEIBA to be incorporated into standard treatment of post-bypass coagulopathic bleeding.

Treatment:

Drug: FEIBA

Placebo Group

Placebo Comparator group

Description:

Pediatric patients ≤15 kg of weight, undergoing cardiac surgery with cardiopulmonary bypass will receive a placebo to be incorporated into standard treatment of post-bypass coagulopathic bleeding.

Treatment:

Drug: Placebo