Condition category
Surgery
Date applied
30/03/2005
Date assigned
10/05/2005
Last edited
14/05/2015
Prospective/Retrospective
Prospectively 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

Mr Christopher Watson

ORCID ID

Contact details

Department of Surgery
Box 202
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

2005-001495-12

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A multi-centre, randomised, controlled study of pre-transplant machine perfusion of heart-beating donor kidneys prior to renal transplantation

Acronym

HBDPump 2005

Study hypothesis

Primary objective:
To determine whether a brief period of machine perfusion reduces the incidence of delayed graft function following renal transplantation.

Secondary objective:
To evaluate the cost effectiveness of a brief period of machine perfusion prior transplantation.

Please note that as of 24/02/2009 this record was updated to include amendments to the trial information. The trial has been changed from single centre to multicentre, and the acronym has been altered from 'CamPump' to the current acronym. At this time, the trial dates on this record were also amended; the overall trial dates at the time of registration were:
Initial overall trial start date: 01/08/2005
Initial overall trial end date: 31/08/2010

Ethics approval

The London Research Ethics Committee (REC), 02/02/2006, ref: 05/MRE02/75

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Kidney preservation prior to transplantation

Intervention

Machine perfusion of the kidney before transplantation versus simple cold storage

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Incidence of delayed graft function at 7 days

Secondary outcome measures

1. Patient survival
2. Graft survival
3. Graft function - estimated glomerular filtration rate (GFR)
4. Acute rejection incidence
5. Acute rejection severity
6. Incidence of steroid resistant rejection, defined as the need for ATG therapy

Overall trial start date

28/06/2006

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (aged 18 years and over, either gender) undergoing transplantation of a kidney from a heart-beating cadaver donor.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Added 24/02/2009: Multi-organ recipient

Recruitment start date

28/06/2006

Recruitment end date

30/06/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Addenbrooke's Hospital (UK)

Sponsor details

Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Hospital/treatment centre

Funder name

Addenbrooke's Hospital (UK) - transplant research fund

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