Safety and Efficacy of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients

Study Overview
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Brief Summary
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The investigators primary objective is to determine if acute normovolemic hemodilution (ANH) for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period as compared to usual care. This study will enroll 24 pediatric heart surgery patients, aged 6 months to 3 years old undergoing either ANH prior to initiating cardiopulmonary bypass or the standard of care procedures for the use of cardiopulmonary bypass.

Detailed Description
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Blood transfusion has been associated with worse outcomes in pediatric cardiac surgical patients. The major complications associated with it include increased blood loss during and after surgery, kidney disease requiring dialysis, abnormal coagulation profile, increased vasopressor use, and increased time spent on the ventilator and in the intensive care unit. One strategy to minimize blood product administration is acute normovolemic hemodilution (ANH). The investigators primary aim is to determine if ANH for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period, compared to usual care. The investigators designed a randomized, controlled, open label study that equally assigns 24 pediatric cardiac surgery patients aged 6 months to 3 years into two groups to receive either ANH prior to initiating cardiopulmonary bypass or usual standard of care. Participants in the ANH arm of the study will have 10 ml/kg of blood removed following anesthetic induction. In order to maintain normal circulating volume, the collected blood will be replaced with an equal volume of 5% albumin. All participants will be treated with a standardized protocol aimed at blood conservation including the use of retrograde arterial and antegrade venous perfusion, small circuit size, intraoperative red blood cell salvage, and low hemoglobin targets to trigger transfusion.

Official Title
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The Efficacy and Safety of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients

Conditions
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Cardiac Defect

Intervention / Treatment
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* Procedure: Acute Normovolemic hemodilution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed signed consent must be obtained by a legally authorized representative. Must be undergoing an elective surgical repair or palliation of a cardiac defect with the use of the cardiopulmonary bypass machine. Must be clinically stable at the time of evaluation for eligibility and on the day of randomization. Exclusion Criteria: Patients who carry a diagnosis of a bleeding disorder. Patients who have an abnormal coagulation profile as evidenced by a preoperative coagulation screen. Patients who have received a blood transfusion in the preceding 120 days. Patients who have a diagnosis of a chromosomal abnormality. Patients whose participation in the study is deemed unsafe by their primary care team.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care Control<br>This group will consist of all the participants that receive the standard of care treatment for elective surgical repair or palliation of their cardiac defect with the use of the cardiopulmonary bypass machine. | |
| Experimental: Acute Normovolemic Hemodilution<br>This group will consist of all the participants that receive the acute normovolemic hemodilution prior to their elective surgical repair or palliation of their cardiac defect with the use of the cardiopulmonary bypass machine. | Procedure: Acute Normovolemic hemodilution<br>* ANH is a technique in which a portion of the patients' own blood is removed before any surgical bleeding occurs. It is stored until the end of the operation, at which point it is returned to the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of ANH to decrease volume of blood products during surgery and the immediate post-operative period. | This will be measured by comparing the volume (mL/Kg body weight) of any blood products administered peri-operatively between the two groups. | 2 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney function | This will be measured by the change in creatinine on postoperative day 2 from the pre-operative baseline value | 2 days | 
| Normalization of thromboelastogrpahy (TEG) MA value (maximum amplitude) | This will be measured by thromboelastography (TEG) test following end of cardiopulmonary bypass | 2 days | 
| Normalization of thromboelastography (TEG) R value (reaction time) | This will be measured by thromboelastography (TEG) test following end of cardiopulmonary bypass | 2 days | 
| Normalization of thromboelastography (TEG) Alpha Angle value | This will be measured by thromboelastography (TEG) test following end of cardiopulmonary bypass | 2 days | 
| Final hematocrit, platelet count, PT/PTT on ICU admission | These lab values will be recorded and compared for each group. | 1 day | 
| Hematocrit and platelet count on post-operative day 1 | These lab values will be recorded and compared for each group. | 1 days | 
| Time to end of vasoactive support in the first 24 hours post-operation. | This value will be recorded and compared for each group. | 1 days | 
| Duration of mechanical ventilation and ICU stay | This value will be recorded and compared for each group. | 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Cardiac, Surgery