Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2003/6589 (NRR No.: N0016131981)
Study information
Scientific title
Acronym
Study hypothesis
We propose that leukocyte extravasation and the release of inflammatory mediators into cantharidin skin blisters will be enhanced during cardiopulmonary bypass and that the effect of aprotinin or off-pump coronary artery surgery will ablate this
Ethics approval
Approved by Hammersmith Hospital and Queen Charlotte's Chelsea Hospitals Research Ethics Committee on 15/07/2003, reference number: 2003/6589
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
Ischaemic heart disease
Intervention
Coronary artery bypass surgery, with or without cardiopulmonary bypass, with or without use of aprotinin infusion
Intervention type
Drug
Phase
Not Specified
Drug names
Aprotinin
Primary outcome measures
1. Leukocyte trafficking into skin blisters - total and differential count
2. Measurement of inflammatory mediators within blister fluid
Secondary outcome measures
Cellular phenotype within blister fluid - activation markers on cell surface
Overall trial start date
01/01/2004
Overall trial end date
14/10/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Primary, elective, coronary artery bypass surgical patients, between ages 45-75 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48
Participant exclusion criteria
1. Pregnancy
2. Myocardial infarction in previous six weeks
3. On steroid medication
4. Malignancy
5. Chronic inflammatory disorder
Recruitment start date
01/01/2004
Recruitment end date
14/10/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
British Heart Foundation Cardiovascular Medicine
London
W12 0NN
United Kingdom
Funders
Funder type
Charity
Funder name
British Heart Foundation grant for clinical PhD studentship number: FS/03/065/15951
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
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18455576
Publication citations
-
Results
Evans BJ, Haskard DO, Finch JR, Hambleton IR, Landis RC, Taylor KM, The inflammatory effect of cardiopulmonary bypass on leukocyte extravasation in vivo., J. Thorac. Cardiovasc. Surg., 2008, 135, 5, 999-1006, doi: 10.1016/j.jtcvs.2007.08.071.