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
Secondary identifying numbers	N0265006856

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

Mr JAJ Hyde
Scientific

Cardiac Services
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2004
Completion date	01/01/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

Cardiac Services

Birmingham
B15 2TH
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

University Hospital Birmingham NHS Trust (UK)

No information available

Research Funds

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan