A comparison of intermittent aortic cross clamping and intermittent aortic warm blood cardioplegia for myocardial protection during coronary artery bypass surgery
| ISRCTN | ISRCTN43177829 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43177829 |
| Protocol serial number | N0265006856 |
| Sponsor | Department of Health |
| Funders | University Hospital Birmingham NHS Trust (UK), Research Funds |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 13/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr JAJ Hyde
Scientific
Scientific
Cardiac Services
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Is the newer technique of intra-aortic warm blood cardioplegia superior to the established technique of intermittent aortic cross-clamping for myocardial protection during coronary surgery? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Coronary artery bypass grafting (CABG) |
| Intervention | 40 patients undergoing elective CABG will randomly be allocated into two groups of 20 patients each, to receive either intermittent cross clamp with fibrillation (XCF) or intermittent warm blood cardioplegia (WBC). Blood will be taken from in-situ intra-arterial or intravenous cannulae, at the following 12 time points: Following induction of anaesthesia; Following institution of cardiopulmonary bypass, but prior to the application of an aortic cross clamp with resultant myocardial ischaemia; 30,60,90,120 minutes and 4,6,8,12,24,28 hours following final release of the aortic cross clamp. The blood will be centrifuged for serum, which will be stored frozen at -70C until batch analysis. The analysis will be performed blind. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | Patients undergoing elective CABG |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cardiac Services
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
