Health Condition 1: Q248- Other specified congenital malformations of heart
Conditions
Interventions
Intervention1: Whole Blood Transfusion: Fresh Whole Blood Collected within 5 days will be transfused
Control Intervention1: Packed Red Blood Cells: Packed Red Blood Cells will be transfused
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean transfusion requirement (ml/kg) 2. Mean length of stay in the intensive care unit 3.Mean length of stay in the hospital 4.Mean chest tube loss mL/kg 5. Difference in mean hemoglobin, coagulogram (PT, aPTT, INR, serum fibrinogen) and platelet count Timepoint: 4 hours 12 hours 24 hours | — |
Primary
| Measure | Time frame |
|---|---|
| Difference in mean donor exposures 24-hours post operativelyTimepoint: 24 hours | — |
Countries
India
Contacts
Public ContactDr Sheetal Malhotra
Postgraduate Institute of Medical Education and Research
Outcome results
None listed