The Effect of Coating of the Cardiopulmonary Bypass Circuit with Poly-2-methoxyethylacrylate (PMEA) on the Systemic Inflammatory Response
| ISRCTN | ISRCTN42608249 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42608249 |
| Secondary identifying numbers | N0295142271 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 18/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Moninder Bhabra
Scientific
Scientific
Cardiothoracic Unit, 3rd floor
UHCW NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Not provided at time of registration. |
| Study objectives | To compare outcomes in patients undergoing coronary artery bypass grafting using either standard non-coated cardiopulmonary circuits or circuits in which all components have been coated with PMEA. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Cardiopulmonary bypass |
| Intervention | Prospective randomised controlled trial |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Post-operative blood loss and transfusion requirements, pulmonary, renal, neurological, cardiac and infective complications during hospitalisation, duration of ICU and hospital stay and thirty day mortality. The magnitude of the inflammatory response will be assessed by measuring plasma levels of inflammatory mediators. Platelet function and coagulation will be assessed by flow cytometry and thromboelastography. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 19/04/2004 |
| Completion date | 30/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 40 |
| Key inclusion criteria | Patients undergoing first-time, isolated, elective coronary artery bypass grafting at UHCW, who have not taken any anti-platelet medication for five days previous to the operation, will be eligible for the study. We aim to recruit 40 patients. |
| Key exclusion criteria | 1. Patients undergoing repeated surgery 2. Patients undergoing emergency surgery 3. Patients taking antiplatelet medication |
| Date of first enrolment | 19/04/2004 |
| Date of final enrolment | 30/10/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cardiothoracic Unit, 3rd floor
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
University Hospitals Coventry and Warwickshire NHS Trust (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/10/2017: No publications found in PubMed, verifying study status with principal investigator.
