Contact information
Type
Scientific
Primary contact
Dr Fraser Douglas Rubens
ORCID ID
Contact details
Room H3403
Ottawa Heart Institute
40 Ruskin St.
Ottawa
K1Y 4W7
Canada
+1 613 761 4720
frubens@ottawaheart.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-44149; MCT-70885
Study information
Scientific title
Clinical relevance of cardiotomy blood salvage during cardiopulmonary bypass: a randomised controlled trial
Acronym
Study hypothesis
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
University of Ottawa Heart Institute Human Research Ethics Board-HREB approved on the 1st June 2001
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/10/2001
Overall trial end date
31/03/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
274
Participant 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
Recruitment start date
01/10/2001
Recruitment end date
31/03/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Room H3403
Ottawa
K1Y 4W7
Canada
Sponsor information
Organisation
University of Ottawa Heart Institute (Canada)
Sponsor details
c/o Claude Duguay
Rm. 2129
451 Smyth Rd
Ottawa
K1H 8M5
Canada
+1 613 562 5800 ext. 8001
cduguay@uottawa.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44149 and MCT-70885)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17846332
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18805154
Publication citations
-
Results
Rubens FD, Boodhwani M, Mesana T, Wozny D, Wells G, Nathan HJ, , The cardiotomy trial: a randomized, double-blind study to assess the effect of processing of shed blood during cardiopulmonary bypass on transfusion and neurocognitive function., Circulation, 2007, 116, 11 Suppl, I89-97, doi: 10.1161/CIRCULATIONAHA.106.678987.
-
Results
Boodhwani M, Nathan HJ, Mesana TG, Rubens FD, , Effects of shed mediastinal blood on cardiovascular and pulmonary function: a randomized, double-blind study., Ann. Thorac. Surg., 2008, 86, 4, 1167-1173, doi: 10.1016/j.athoracsur.2008.06.029.