Skip to content

Clinical relevance of cardiotomy blood salvage during cardiopulmonary bypass

Clinical relevance of cardiotomy blood salvage during cardiopulmonary bypass: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87590585
Enrollment
274
Registered
2005-09-26
Start date
2001-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease - Cardiopulmonary bypass Circulatory System Chronic ischaemic heart disease

Interventions

The control group receives the current practice of cardiotomy blood re-infusion during the operation. The experimental group is re-infused with centrifugally washed blood, which is passed through an a

Sponsors

University of Ottawa Heart Institute (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult patients scheduled for coronary artery bypass grafting requiring CPB 2. Aged greater than or equal to 18 years old, either sex

Exclusion criteria

Exclusion criteria: 1. Emergency surgery 2. Patients unable to undergo cognitive testing (visual or motor problems, unable to speak English or French) 3. Undergoing reoperative surgery 4. Patients undergoing non-CABG procedures or other cardiac procedures in addition to CABG 5. Patients with preoperative coagulopathy, bleeding diathesis or thrombocytopenia (less than 140,000 /µl) 6. Patients with renal insufficiency (creatinine 2 x normal) or hepatic insufficiency (elevated liver function tests, elevated baseline international normalised ratio [INR]) 7. Mini-Mental State Examination (MMSE) less than 24/30 at pre-operative visit

Design outcomes

Primary

MeasureTime frame
1. The proportion of patients requiring one or more red cell transfusions during hospital stay 2. Incidence of cognitive deficits at 5 - 7 days

Secondary

MeasureTime frame
1. Blood loss (protamine administration to chest closure and first 24 hours) Within 3 - 5 days after surgery: 2. Total non-red cell transfusion requirements (blood factors, platelets) 3. Pulmonary function after CPB (pulmonary vascular resistance, A-a gradient, pO2 after CPB, shunt, dynamic pulmonary compliance, oxygen delivery index, oxygen extraction rate) 4. Incidence of emboli during CPB by trans-cranial Doppler (TCD) 5. Quality of life at 3 months 6. Cognitive deficits at 3 months

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026