FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FEIBA Group

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.

Group Type EXPERIMENTAL

FEIBA

Intervention Type DRUG

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 Group

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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activated prothrombin complex concentrate (aPCC) FEIBA

Eligibility Criteria

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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").

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No