A randomised controlled trial on short term outcomes of using Fresh whole blood and Packed red blood cells for priming in cardiopulmonary bypass in neonatal and pediatric cardiac surgery
Phase 2
- Conditions
- Health Condition 1: Q248- Other specified congenital malformations of heart
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age less than 1 year
2.Undergoing elective cardiac surgery.
3.Requiring cardiopulmonary bypass during cardiac surgery.
4.Children of parents who provide consent for the study.
Exclusion Criteria
1. Those children whose parents do not give consent for the study
2. Those who cannot be followed up during the study period.
3. Those children with pre-existing blood dyscrasias.
4. Emergency cases.
5. Patients not requiring CPB
6. Patient not fit to receive the blood product as per randomization due to clinical reasons
7. Recent antiplatelet or anticoagulation therapy
8. Patients undergoing complex surgery/repeat open heart surgery
9. Patients with rare blood groups and alloantibodies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in mean donor exposures 24-hours post operativelyTimepoint: 24 hours
- Secondary Outcome Measures
Name Time Method 1. Mean transfusion requirement (ml/kg) <br/ ><br>2. Mean length of stay in the intensive care unit <br/ ><br>3.Mean length of stay in the hospital <br/ ><br>4.Mean chest tube loss mL/kg <br/ ><br> 5. Difference in mean hemoglobin, coagulogram (PT, aPTT, INR, serum fibrinogen) and platelet count <br/ ><br>Timepoint: 4 hours <br/ ><br>12 hours <br/ ><br>24 hours