A randomised controlled study of N-Acetylcysteine in liver transplantation
| ISRCTN | ISRCTN46492332 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46492332 |
| Secondary identifying numbers | N0544103857 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 07/04/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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 Christopher Watson
Scientific
Scientific
Honorary Consultant Surgeon
University Department of Surgery
Box 202
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 336980 |
|---|---|
| cjew2@cam.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | |
| Study objectives | N-Acetylcysteine in liver transplantation |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Liver transplant |
| Intervention | Patients undergoing liver transplantation will be randomly allocated to the N-Acetylcysteine group or a control group (no treatment). Treatment will commence during the liver transplant and continue for 5 days post-operatively. Blood tests and liver biopsies will be taken during the study for analysis. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | N-Acetylcysteine |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 06/09/2001 |
| Completion date | 01/09/2007 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Added May 2008: 170 patients would give 90% power but trial stopped. |
| Key inclusion criteria | Added May 2008: Adult patients (≥18years) undergoing liver transplant |
| Key exclusion criteria | Added May 2008: Allergy to n-acetyl cysteine |
| Date of first enrolment | 06/09/2001 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Honorary Consultant Surgeon
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Cambridge Consortium - Addenbrooke's (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 |
