Internal mammary artery harvest with papaverine vs saline infiltration
| ISRCTN | ISRCTN62199147 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62199147 |
| Protocol serial number | N0436176306 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 29/01/2015
- 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 Unnikrishnan Nair
Scientific
Scientific
Cardiothoracic Surgery Department
Yorkshire Heart Centre, D Floor
Jubilee Building
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 392 5792 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Internal mammary artery harvest with papaverine vs saline infiltration |
| Study objectives | To see whether infiltrating papaverine into endothoracic fascia while harvesting compared to saline as reported in literature makes any difference in terms of spasm, size and flow difference in the mammary conduit. |
| Ethics approval(s) | Leeds East Ethics Committee, ref 05/Q1206/185 |
| Health condition(s) or problem(s) studied | Surgery: Coronary artery bypass graft (CABG) |
| Intervention | Internal thoracic artery (IMA) harvest with papaverine vs normal saline infiltration into endothoracic fascia |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Papaverine |
| Primary outcome measure(s) |
To see the difference in quality of mammary artery conduit with two different methods of harvesting (quality of the mammary artery that includes the spasm, flow and appearances). |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | All patients having coronary artery bypass surgery where artery behind the breast bone is used will be invited to take part. |
| Key exclusion criteria | 1. Patients not willing to participate 2. Internal Mammary Artery (IMA) not used |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 01/07/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
LS1 3EX
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 |
