Massive post-operative bleeding in high risk cardiac patients Signs and Symptoms Post operative bleeding
Conditions
Interventions
Group 1: Aprotinin (2 million unit bolus and 2 million units in pump prime and 2 million units via infusion over 4 hours)
Group 2: Tranexamic acid (100 mg/kg post induction) or epsilon-amnicaproic aci
Sponsors
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and older, either sex 2. Re-operation for coronary artery bypass graft (CABG) 3. Re-operation for aortic valve replacement with a CABG 4. Mitral valve replacement (initial or re-operation) 5. Aortic and mitral valve replacement with a CABG 6. Multiple valve replacement (initial or reoperation) 7. Other procedures including Bental procedure and re-operation for adult congenital heart procedures
Exclusion criteria
Exclusion criteria: 1. Less than 18 years of age 2. Refuse consent (refusal from patient or physician) 3. Have a terminal illness with a life expectancy less than 3 months. 4. Have been previously enrolled in this study 5. Are currently enrolled in another perioperative interventional study 6. Are unable to receive blood products 7. Have had previous exposure to aprotinin 8. Have a thrombocytopenia defined as a platelet count less than 100,000/mm^3 9. Have a coagulopathy defined as an International Normalised Ratio (INR) equalling 1.5 prior to surgery or the immediate preoperative use of tPA or streptokinase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Massive post-operative bleeding. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 30 day all cause mortality 2. Myocardial infarction 3. Cerebrovascular accidents (focal neurologic deficit lasting more than 24 hours 4. Dialysis dependent renal failure by a double of creatinine 5. Need for prolonged invasive mechanical ventilatory support (greater than 48 hours) 6. A prolonged low output state (need for vasopressors, balloon pump or ventricular assist device for more than 48 hours) | — |
Countries
Canada
Outcome results
None listed