Condition category
Circulatory System
Date applied
04/07/2005
Date assigned
10/07/2006
Last edited
14/12/2010
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

Prof Dorian Haskard

ORCID ID

Contact details

British Heart Foundation Cardiovascular Medicine
Imperial College School of Medicine
Hammersmith Hospital Campus
Du Cane Road
London
W12 0NN
United Kingdom

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

Sponsor information

Organisation

Hammesmith Hospital NHS Trust (UK)

Sponsor details

Du Cane Road
London
W12 0NN
United Kingdom

Sponsor type

Government

Website

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

  1. 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.

Additional files

Editorial Notes