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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN30610605 |
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Date of registration:
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12/05/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cellular stress and inflammation with miniature cardiopulmonary bypass
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Scientific title:
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Does mini-cardiopulmonary bypass (CPB) reduce cellular stress and inflammation compared with standard CPB? |
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Date of first enrolment:
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01/06/2010 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN30610605 |
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Study type:
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Interventional |
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Study design:
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Single-centre randomised interventional diagnosis, prevention, process of care and treatment (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Bao
Nguyen |
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Address:
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Department of Cardiothoracic Sciences
National Heart and Lung Institute
Hammersmith Hospital
Du Cane Road
W12 0NN
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age range 18+ years
2. No gender discrimination
3. Patients referred for elective coronary artery bypass grafting (CABG)
4. Not participated in any other clinical trial
Exclusion criteria: 1. Patients less than 18 years of age
2. Emergency cases
3. Combined valvular procedures
4. Redo operations
5. Poor left ventricular function (ejection fraction less than 30%)
6. Cerebro-vascular accident within 3 months pre-operatively or more than 75% carotid artery obstruction as shown by carotid Doppler scan
7. Serum creatinine in excess of 177 µmol/L
8. Pre-existing coagulopathy
9. Pre-existing liver dysfunction
10. Recent (within 5 days) use of antiplatelets (aspirin/clopidogrel)
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Circulatory System
Cardiopulmonary bypass
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Intervention(s)
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All patients referred for primary elective coronary artery bypass grafting (CABG) will be considered for inclusion within the clinical trial. Trial participants will be randomised into one of three different treatment groups:
1. Positive control group in whom standard CPB is used
2. Negative control group in whom CPB is not used at all ('off pump' group)
3. Investigative group in which the mini-CPB technique is used ('miniCPB' group)
Participants will be reviewed up until they are discharged from hospital. Intervention timings are as follows:
Blood tests:
1. Pre-op (baseline)
2. Post induction
3. Start of CPB
4. 15 minutes CPB
5. 30 minutes CPB
6. 45 minutes CPB
7. 60 minutes CPB
8. 2 hours CPB
9. 6 hours CPB
10. 24 hours CPB
Cantharadin blister tests:
1. Pre-op (baseline)
2. CPB 5 hours
Myocardial tissue sampling:
1. Start of CPB
2. Before end of CPB
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Primary Outcome(s)
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Blood parameters of cellular stress - reactive oxygen species detection; p38 MAP kinase signalling
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Secondary Outcome(s)
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Supporting conventional markers of the inflammatory response will be measured including white cell count
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Source(s) of Monetary Support
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Heart Research UK (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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