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

NCT ID: NCT02751645

Last Updated: 2019-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-05-31

Brief Summary

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

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.

Conditions

Cardiac Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Acute Normovolemic hemodilution

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Gerber Foundation

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Weronika Crescini, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miriam Treggiari, MD

Role: STUDY_DIRECTOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

IRB#: 11949

Identifier Type: -

Identifier Source: org_study_id