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

Status unconfirmed · Not applicable

Conditions studied: Cardiac Defect

In brief

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.

Key facts

Study ID

NCT02751645

Run by

Oregon Health and Science University

People needed

24

Starts

2016-06-30

Expected to finish

2020-05-31

Last updated by the study team

2019-05-16

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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