Clinical relevance of cardiotomy blood salvage during cardiopulmonary bypass

ISRCTN	ISRCTN87590585
DOI	https://doi.org/10.1186/ISRCTN87590585
Protocol serial number	MCT-44149; MCT-70885
Sponsor	University of Ottawa Heart Institute (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44149 and 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

Room H3403
Ottawa Heart Institute
40 Ruskin St.
Ottawa
K1Y 4W7
Canada

Phone	+1 613 761 4720
Email	frubens@ottawaheart.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	1. The proportion of patients requiring one or more red cell transfusions during hospital stay 2. Incidence of cognitive deficits at 5 - 7 days
Key secondary outcome measure(s)	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
Completion date	31/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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