Pre-transplant machine perfusion of heart-beating donor kidneys prior to renal transplantation

ISRCTN ISRCTN35082773
DOI https://doi.org/10.1186/ISRCTN35082773
Clinical Trials Information System (CTIS) 2005-001495-12
Protocol serial number N/A
Sponsor Addenbrooke's Hospital (UK)
Funder Addenbrooke's Hospital (UK) - transplant research fund
Submission date
30/03/2005
Registration date
10/05/2005
Last edited
10/08/2017
Recruitment status
No longer recruiting
Overall study status
Completed
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

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA multi-centre, randomised, controlled study of pre-transplant machine perfusion of heart-beating donor kidneys prior to renal transplantation
Study acronymHBDPump 2005
Study objectivesPrimary 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(s)The London Research Ethics Committee (REC), 02/02/2006, ref: 05/MRE02/75
Health condition(s) or problem(s) studiedKidney preservation prior to transplantation
InterventionMachine perfusion of the kidney before transplantation versus simple cold storage
Intervention typeProcedure/Surgery
Primary outcome measure(s)

Incidence of delayed graft function at 7 days

Key secondary outcome measure(s)

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

Completion date30/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration200
Key inclusion criteriaPatients (aged 18 years and over, either gender) undergoing transplantation of a kidney from a heart-beating cadaver donor.
Key exclusion criteriaAdded 24/02/2009: Multi-organ recipient
Date of first enrolment28/06/2006
Date of final enrolment30/06/2012

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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

Editorial Notes

10/08/2017: No publications found in PubMed, verifying study status with principal investigator.

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