Investigation of leukocyte trafficking into skin blisters during cardiopulmonary bypass

ISRCTN ISRCTN60289857
DOI https://doi.org/10.1186/ISRCTN60289857
Secondary identifying numbers 2003/6589 (NRR No.: N0016131981)
Submission date
04/07/2005
Registration date
10/07/2006
Last edited
14/12/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Dorian Haskard
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesWe 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(s)Approved by Hammersmith Hospital and Queen Charlotte's Chelsea Hospitals Research Ethics Committee on 15/07/2003, reference number: 2003/6589
Health condition(s) or problem(s) studiedIschaemic heart disease
InterventionCoronary artery bypass surgery, with or without cardiopulmonary bypass, with or without use of aprotinin infusion
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Aprotinin
Primary outcome measure1. Leukocyte trafficking into skin blisters - total and differential count
2. Measurement of inflammatory mediators within blister fluid
Secondary outcome measuresCellular phenotype within blister fluid - activation markers on cell surface
Overall study start date01/01/2004
Completion date14/10/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants48
Key inclusion criteriaPrimary, elective, coronary artery bypass surgical patients, between ages 45-75 years
Key exclusion criteria1. Pregnancy
2. Myocardial infarction in previous six weeks
3. On steroid medication
4. Malignancy
5. Chronic inflammatory disorder
Date of first enrolment01/01/2004
Date of final enrolment14/10/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

British Heart Foundation Cardiovascular Medicine
London
W12 0NN
United Kingdom

Sponsor information

Hammesmith Hospital NHS Trust (UK)
Hospital/treatment centre

Du Cane Road
London
W12 0NN
England
United Kingdom

ROR logo "ROR" https://ror.org/056ffv270

Funders

Funder type

Charity

British Heart Foundation grant for clinical PhD studentship number: FS/03/065/15951

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2008 Yes No