Blood conservation using antifibrinolytics in cardiac surgery

Completed

Conditions: Massive post-operative bleeding in high risk cardiac patients
Signs and Symptoms
Post operative bleeding

Registration Number: ISRCTN15166455

Lead Sponsor: Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 2970

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Massive post-operative bleeding.

Secondary Outcome Measures

Name	Time	Method
1. 30 day all cause mortality<br>2. Myocardial infarction<br>3. Cerebrovascular accidents (focal neurologic deficit lasting more than 24 hours<br>4. Dialysis dependent renal failure by a double of creatinine<br>5. Need for prolonged invasive mechanical ventilatory support (greater than 48 hours)<br>6. A prolonged low output state (need for vasopressors, balloon pump or ventricular assist device for more than 48 hours)