FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients

Cardiac Disease Clinical Trial

Official title:

Activated Prothrombin Complex Concentrate FEIBA to Optimize Postcardiopulomonary Bypass Hemostasis in Pediatric Cardiac Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05020483
• Other study ID #: 21-005539
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 2021
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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").

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Drug:
• FEIBA
Administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously. Three small doses, 5 mg/kg each, will be available.
• Placebo
Contains no active ingredient and administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of units of allogeneic blood products required early perioperatively in pediatric cardiac patients.	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.	approximately 1 day postoperatively
Secondary	Hospital length of stay	Number of days admitted to the hospital	Through hospital discharge, approximately 3 days
Secondary	Mortality	Total number of subject deaths	Through hospital discharge, approximately 3 days
Secondary	Intravascular and intracardiac thromboses	Number of subjects to experience intravascular and/or intracardiac thromboses up to POD 3	approximately 3 days postoperatively

External Links

•   Mayo Clinic Clinical Trials