At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
transfusion strategy +1 moreother
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.
A Prospective, Randomized, Controlled Clinical Trial Comparing Two Transfusion Strategies in Pediatric Patients Undergoing Cavopulmonary Connection.
In Brief
A Phase 2 clinical trial evaluating transfusion strategy and Low Hb transfusion group for Congenital Heart Disease. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects. These children often receive red blood cell transfusions after surgery, but what the best hemoglobin level is for them remains unknown.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedJul 2006
Primary CompletionSep 2009
TodayJul 2026
First PostedJul 10, 2006
Enrollment StartJul 1, 2006
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 20.0 years ago
Interventions
transfusion strategyother
For the High Hb group; transfusions will be given to keep the Hb \>13.0 g/dl
Low Hb transfusion groupother
RBCs will not be transfused unless the Hb \< 9.0 g/dl