A randomised controlled study of N-Acetylcysteine in liver transplantation
| ISRCTN | ISRCTN46492332 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46492332 |
| Protocol serial number | N0544103857 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrooke's (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | N-Acetylcysteine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 170 |
| 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
- United Kingdom
- England
Study participating centre
Honorary Consultant Surgeon
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
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 |
