Contact information
Type
Scientific
Contact name
Mr Christopher Watson
ORCID ID
Contact details
Honorary Consultant Surgeon
University Department of Surgery
Box 202
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 336980
cjew2@cam.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0544103857
Study information
Scientific title
Acronym
Study hypothesis
N-Acetylcysteine in liver transplantation
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
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
Overall study end date
01/09/2007
Reason abandoned (if study stopped)
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
Added May 2008:
Adult patients (≥18years) undergoing liver transplant
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.
Participant exclusion criteria
Added May 2008:
Allergy to n-acetyl cysteine
Recruitment start date
06/09/2001
Recruitment end date
01/09/2007
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Honorary Consultant Surgeon
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Cambridge Consortium - Addenbrooke's (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|