Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 number

ClinicalTrials.gov number

Protocol/serial number

N0544103857

Study information

Scientific title

Acronym

Study hypothesis

N-Acetylcysteine in liver transplantation

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

N-Acetylcysteine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

06/09/2001

Overall trial end date

01/09/2007

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant inclusion criteria

Added May 2008:
Adult patients (≥18years) undergoing liver transplant

Participant type

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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

http://www.doh.gov.uk

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes