Phase 2 N=60 Randomized Treatment

Transfusion Strategies in Pediatric Cardiothoracic Surgery

Congenital Heart Disease

Bottom Line

View on ClinicalTrials.gov: NCT00350220 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2010

Primary outcome: Primary: Mean Arterial Lactate Level — 1.4; 1.4 mmol/L

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: transfusion strategy (Other); Low Hb transfusion group (Other)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Arterial Lactate Level	1.4; 1.4	—
PRIMARY Peak Arterial Lactate Level	3.2; 3.1	—
SECONDARY Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.	—	—
SECONDARY Length of Mechanical Ventilation	—	—
SECONDARY Length of Oxygen Use	—	—
SECONDARY Length of Vasoactive Agent Administration	—	—
SECONDARY Volume of Blood Transfused	—	—
SECONDARY Mortality Before Hospital Discharge	—	—

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.

Eligibility Criteria

Inclusion Criteria

4 months to 6.99 years of age
surgical candidates for cavopulmonary connection
English speaking

Exclusion Criteria

presence of known bleeding disorder
presence of known coagulopathy
age 7 years
non-English speaking

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00350220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.