Investigation of leukocyte trafficking into skin blisters during cardiopulmonary bypass
| ISRCTN | ISRCTN60289857 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60289857 |
| Protocol serial number | 2003/6589 (NRR No.: N0016131981) |
| Sponsor | Hammesmith Hospital NHS Trust (UK) |
| Funder | British Heart Foundation grant for clinical PhD studentship number: FS/03/065/15951 |
- 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
Scientific
British Heart Foundation Cardiovascular Medicine
Imperial College School of Medicine
Hammersmith Hospital Campus
Du Cane Road
London
W12 0NN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | Aprotinin |
| Primary outcome measure(s) |
1. Leukocyte trafficking into skin blisters - total and differential count |
| Key secondary outcome measure(s) |
Cellular phenotype within blister fluid - activation markers on cell surface |
| Completion date | 14/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 48 |
| Key inclusion criteria | Primary, elective, coronary artery bypass surgical patients, between ages 45-75 years |
| Key exclusion criteria | 1. Pregnancy 2. Myocardial infarction in previous six weeks 3. On steroid medication 4. Malignancy 5. Chronic inflammatory disorder |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 14/10/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
British Heart Foundation Cardiovascular Medicine
London
W12 0NN
United Kingdom
W12 0NN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
