Clinical relevance of cardiotomy blood salvage during cardiopulmonary bypass
| ISRCTN | ISRCTN87590585 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87590585 |
| Secondary identifying numbers | MCT-44149; MCT-70885 |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 06/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Fraser Douglas Rubens
Scientific
Scientific
Room H3403
Ottawa Heart Institute
40 Ruskin St.
Ottawa
K1Y 4W7
Canada
| Phone | +1 613 761 4720 |
|---|---|
| frubens@ottawaheart.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Clinical relevance of cardiotomy blood salvage during cardiopulmonary bypass: a randomised controlled trial |
| Study objectives | Blood collected in the pericardial wall during cardiopulmonary bypass (cardiotomy blood) is a contributor to diffuse neurologic injury after cardiac surgery. This effect may be ameliorated by the processing of the blood such that only the red cell component is returned, however this step may compound bleeding after heart surgery due to loss of coagulation factors. Objective: To evaluate the effects of cardiotomy blood centrifugation & filtration on: 1. Intra- and post-operative blood loss and homologous transfusion requirements 2. Neuropsychologic deficits following CPB 3. Early pulmonary function & gas exchange after CPB |
| Ethics approval(s) | University of Ottawa Heart Institute Human Research Ethics Board-HREB approved on the 1st June 2001 |
| Health condition(s) or problem(s) studied | Coronary Artery Disease - Cardiopulmonary bypass |
| Intervention | 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 additional lipid/leukocyte filter. Trial details received: 12 Sept 2005 |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/10/2001 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 274 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Room H3403
Ottawa
K1Y 4W7
Canada
K1Y 4W7
Canada
Sponsor information
University of Ottawa Heart Institute (Canada)
University/education
University/education
c/o Claude Duguay
Rm. 2129, 451 Smyth Rd
Ottawa
K1H 8M5
Canada
| Phone | +1 613 562 5800 ext. 8001 |
|---|---|
| cduguay@uottawa.ca | |
| Website | http://www.ottawaheart.ca/UOHI/Welcome.do |
"ROR" |
https://ror.org/03c4mmv16 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44149 and MCT-70885)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/09/2007 | Yes | No | |
| Results article | results | 01/10/2008 | Yes | No |
