At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 171 enrolled
Drug / intervention
cardiac surgical procedures +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Infant Heart Surgery: Central Nervous System Sequelae of Circulatory Arrest
In Brief
A Phase 3 clinical trial evaluating cardiac surgical procedures and cardiopulmonary bypass for Cardiovascular Diseases and 6 related conditions. Completed, enrolled 171 participants.
Detailed Summary
To compare the influence of two surgical anesthetic techniques, hypothermia with circulatory arrest or hypothermia with low-flow bypass perfusion, on neurologic functioning in infants undergoing heart surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases, Cerebral Anoxia, Cerebrovascular Disorders, Defect, Congenital Heart, Heart Diseases, Transposition of Great Vessels, Heart Septal Defects, Ventricular
Countries--
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Timeline
Phase 3CompletedFinished
1988198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 1988
Primary CompletionFeb 1992
Study CompletionOct 1993
First PostedOct 1999
TodayJul 2026
First PostedOct 28, 1999
Enrollment StartDec 1, 1988
Primary CompletionFeb 1, 1992
Study CompletionOct 1, 1993
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 26.7 years ago
Interventions
cardiac surgical proceduresprocedure
cardiopulmonary bypassprocedure