Condition category
Circulatory System
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
11/08/2014
Prospective/Retrospective
Prospectively 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

Mr Bao Nguyen

ORCID ID

Contact details

Department of Cardiothoracic Sciences
National Heart and Lung Institute
Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7937

Study information

Scientific title

Does mini-cardiopulmonary bypass (CPB) reduce cellular stress and inflammation compared with standard CPB?

Acronym

Study hypothesis

Ischaemia-reperfusion, mechanical trauma and other stimuli associated with cardiopulmonary bypass (CPB) can lead to the generation of intracellular reactive oxygen species (ROS). ROS can enhance inflammatory activation via activation of NF-kB, p38 MAP kinase and other pathways. Given that CPB leads to ischaemia and mechanical stimulation of leucocytes, it is likely to induce ROS in leukocytes and other cell types.

Hypotheses:
1. CPB leads to rapid induction of ROS in leukocytes which is associated with early activation of pro-inflammatory signalling (e.g. p38 activation) and with delayed activation of anti-inflammatory/anti-oxidant mechanisms
2. Mini-CPB is associated with reduced ROS/pro-inflammatory activation in leucocytes and attenuated systemic inflammation compared to conventional CPB

Ethics approval

Brompton, Harefield and NHLI Research Ethics Committee, 24/07/2008, ref: 08/H0708/67. Amendment approved on 29/04/2010, ref: AM02.

Study design

Single-centre randomised interventional diagnosis, prevention, process of care and treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Blood parameters of cellular stress - reactive oxygen species detection; p38 MAP kinase signalling

Secondary outcome measures

Supporting conventional markers of the inflammatory response will be measured including white cell count

Overall trial start date

01/06/2010

Overall trial end date

01/06/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 48

Participant 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)

Recruitment start date

01/06/2010

Recruitment end date

01/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Cardiothoracic Sciences
London
W12 0NN
United Kingdom

Sponsor information

Organisation

Imperial College NHS Healthcare Trust (UK)

Sponsor details

Hammersmith Hospital
Research & Development Office
1st Floor
Ham House
Du Cane Road
London
W12 0HS
United Kingdom
becky.ward@imperial.ac.uk

Sponsor type

Hospital/treatment centre

Website

http://www.imperial.nhs.uk/research

Funders

Funder type

Research organisation

Funder name

Heart Research UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2014 substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/24934242

Publication citations

  1. Substudy results

    Nguyen BA, Suleiman MS, Anderson JR, Evans PC, Fiorentino F, Reeves BC, Angelini GD, Metabolic derangement and cardiac injury early after reperfusion following intermittent cross-clamp fibrillation in patients undergoing coronary artery bypass graft surgery using conventional or miniaturized cardiopulmonary bypass., Mol. Cell. Biochem., 2014, 395, 1-2, 167-175, doi: 10.1007/s11010-014-2122-3.

Additional files

Editorial Notes