Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/03/2014
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

Mr JAJ Hyde

ORCID ID

Contact details

Cardiac Services
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265006856

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

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

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing elective CABG

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2004

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiac Services
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

University Hospital Birmingham NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Research Funds

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

Publication citations

Additional files

Editorial Notes