MedTrace Logo

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

NCT02751645 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-05-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Miriam Treggiari, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-12-31
Completion
2020-05-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02751645 on ClinicalTrials.gov