FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients

Study Overview
=================
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.

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

Conditions
-----------------
Cardiac Disease

Intervention / Treatment
-----------------
* Drug: FEIBA
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FEIBA Group<br>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. | Drug: FEIBA<br>* 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.<br>* Other names: activated prothrombin complex concentrate (aPCC) FEIBA;|
| Placebo Comparator: Placebo Group<br>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. | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Surgery