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 |
| Protocol serial number | N0295142271 |
| Sponsor | Department of Health |
| Funders | University Hospitals Coventry and Warwickshire NHS Trust (UK), NHS R&D Support Funding (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Cardiothoracic Unit, 3rd floor
UHCW NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
CV2 2DX
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/10/2017: No publications found in PubMed, verifying study status with principal investigator.
