Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
15/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Brian R Davidson

ORCID ID

Contact details

University Department of Surgery
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0256119281

Study information

Scientific title

Remote ischaemic preconditioning in patients undergoing liver surgery

Acronym

Study hypothesis

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

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

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Liver

Intervention

Blind randomised controlled study

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Does IPC reduce free radical generation and prevent activation of neutrophils observed during IR?

Secondary outcome measures

Not provided at time of registration

Overall trial start date

20/12/2002

Overall trial end date

01/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

48 patients with 24 controls for each category (48 controls in all)

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

48

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

20/12/2002

Recruitment end date

01/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Department of Surgery
London
NW3 2QG
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

Hospital/treatment centre

Funder name

The Royal Free Hampstead NHS Trust (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