FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients

Phase 2

Withdrawn

• Conditions: Cardiac Disease
• Interventions: Drug: Placebo; Drug: FEIBA

• Registration Number: NCT05020483
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-25
• Study Start: 2021-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-05
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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").

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	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.
FEIBA Group	FEIBA	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.

Primary Outcome Measures

Name	Time	Method
Number of units of allogeneic blood products required early perioperatively in pediatric cardiac patients.	approximately 1 day postoperatively	Number of units of transfused allogeneic blood products after cardiopulmonary bypass in the operating room (OR) and in the intensive care unit (ICU) on postoperative day (POD) 0 and 1.

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	Through hospital discharge, approximately 3 days	Number of days admitted to the hospital
Mortality	Through hospital discharge, approximately 3 days	Total number of subject deaths
Intravascular and intracardiac thromboses	approximately 3 days postoperatively	Number of subjects to experience intravascular and/or intracardiac thromboses up to POD 3