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

NCT02751645 | Unknown DMC

• 1 other identifier: IRB#: 11949
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Defect

Keywords

Pediatric; Cardiac; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Kidney function

  2 days

• Normalization of thromboelastogrpahy (TEG) MA value (maximum amplitude)

  2 days

• Normalization of thromboelastography (TEG) R value (reaction time)

  2 days

• Normalization of thromboelastography (TEG) Alpha Angle value

  2 days

• Final hematocrit, platelet count, PT/PTT on ICU admission

  1 day

Study Arms (2)

Standard of Care Control

NO INTERVENTION

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.

Acute Normovolemic Hemodilution

EXPERIMENTAL

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

Interventions

Acute Normovolemic hemodilution 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.

Acute Normovolemic Hemodilution

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• The Gerber Foundation: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Study Officials

• Miriam Treggiari, MD

  Oregon Health and Science University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 26, 2016
• Study Start: June 30, 2016
• Primary Completion: December 31, 2019
• Study Completion: May 31, 2020
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)