Comparison of Hematocrit Levels in Infant Heart Surgery

Completed · Phase 3

Conditions studied: Cardiovascular Diseases, Heart Diseases, Heart Defects, Congenital, Transposition of Great Vessels

In brief

The purpose of this study is to compare the effects of diluted hematocrit (HCT) levels of 35% versus 25% during hypothermic cardiopulmonary bypass (CPB) in infants with d-transposition of the great arteries, a malformation of the heart vessels.

Key facts

Study ID

NCT00006183

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

120

Starts

2000-07-01

Expected to finish

2005-07-01

Last updated by the study team

2016-07-29

Who can join

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

You may qualify if…

• Undergoing repair of ventricular septal defect within 9 months of study entry
• Tetralogy of fallot
• D-transposition of the great arteries
• Atrio-ventricular septal defect

You may not qualify if…

• Birth weight less than 2.3 kg
• Recognizable phenotypic syndrome of congenital anomalies
• Extracardiac anomalies of greater than minor severity
• Previous cardiac surgery
• Associated cardiovascular anomalies requiring aortic arch reconstruction or additional open surgical procedures before the planned developmental follow-up

Where it is running

• Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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