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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Defect
• Intervention / Treatment: Procedure: Acute Normovolemic hemodilution

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care Control; 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: The Gerber Foundation
• Investigators: Study Director: Miriam Treggiari, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2016
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): May 31, 2020

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Surgery; Pediatric; Cardiac
• Other Study ID Numbers: IRB#: 11949

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There are no plans to share the data collected during this study.