Remote ischaemic preconditioning in patients undergoing liver surgery
| ISRCTN | ISRCTN54561358 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54561358 |
| Protocol serial number | N0256119281 |
| Sponsor | Department of Health (UK) |
| Funder | The Royal Free Hampstead NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 07/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Brian R Davidson
Scientific
Scientific
University Department of Surgery
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
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 | Remote ischaemic preconditioning in patients undergoing liver surgery |
| Study objectives | To study the effects of remote ischaemic preconditioning on liver functions following liver resection or transplantation. To determine whether a brief period of leg ischaemia will reduce ischaemia reperfusion (IR) injury to the liver during liver surgery for liver cancers and liver transplantation. On 13/10/2014 the anticipated end date was changed from 30/06/2004 to 01/09/2015. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Liver |
| Intervention | Blind randomised controlled study |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Does IPC reduce free radical generation and prevent activation of neutrophils observed during IR? |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 48 |
| Key inclusion criteria | 48 patients with 24 controls for each category (48 controls in all) |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 20/12/2002 |
| Date of final enrolment | 01/09/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Department of Surgery
London
NW3 2QG
United Kingdom
NW3 2QG
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 | 01/09/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/02/2019: Publication reference added.
