Condition category
Circulatory System
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
06/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ottawaheart.ca/UOHI/Welcome.do

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes