Phase 2
Completed N=60
Transfusion Strategies in Pediatric Cardiothoracic Surgery
Source: ClinicalTrials.gov NCT00350220 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: Mean Arterial Lactate Level — 1.4; 1.4 mmol/L
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.
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 |
— | — |
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
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. Informational only — not medical advice.