FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05020483

Enrollment

Registered

2021-08-25

Start date

2021-10-31

Completion date

2023-12-31

Last updated

2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

Keywords

Cardiac Surgery

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.

Interventions

DRUGFEIBA

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.

DRUGPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

No minimum to 5 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026