Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: 1) Restrictive transfusion strategy
2) Liberal transfusion strategy: Study participants will be randomized to one of the following transfusion strategies in a 1:1
manner:
ï?· Restricti
4.7 mmol/L) intraoperatively and/or postoperatively.
ï?· Liberal transfusion strategy: patients will receive a RBC transfusion if their Hb
concentration is 95 g/L (9.5 g/dL
5.9 mmol/L) intraoperatively, or postoperatively in
the ICU
or 85 g/L (8.5 g/dL
5.3 mmol/L) on the ward.
Sponsors
Dr David Mazer
Eligibility
Inclusion criteria
Inclusion criteria: 1. >=18 and 2. Planned cardiac surgery using cardiopulmonary bypass 3. Informed consent obtained 4. Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more.
Exclusion criteria
Exclusion criteria: 1. Patients who refuse participation 2. Patients who are unable to receive or who refuse blood products 3. Patients who are involved in a preoperative autologous pre-donation program 4. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device 5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is primary composite endpoint of all-cause mortality, myocardial infarction defined in accordance with the 4th Universal Definition of Myocardial Infarction, new-onset renal failure with dialysis, or new focal neurological deficit (stroke) lasting more than 24 hours confirmed by clinical and/or computed tomographic scan, occurring within 6 months of the initial surgeryTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| ) Incidence of each individual component of the primary outcome: all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke) within 6 months 2) Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke) with index hospitalization or after 28 days postoperatively, whichever comes first 3) Length of stay in the Intensive Care Unit (ICU) and hospital (index hospitalization) 4) Prolonged low output state defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump or ventricular assist device postoperatively (index hospitalization) 5) Duration of mechanical ventilation (index hospitalization)Timepoint: 6 Months | — |
Countries
Canada, India, Russian Federation
Contacts
Public ContactDrChirag Mehta
Epic Hospital
Outcome results
None listed