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

ISRCTN	ISRCTN35082773
DOI	https://doi.org/10.1186/ISRCTN35082773
EudraCT/CTIS number	2005-001495-12
Secondary identifying numbers	N/A

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, use contact details to request a patient information sheet
Scientific title	A multi-centre, randomised, controlled study of pre-transplant machine perfusion of heart-beating donor kidneys prior to renal transplantation
Study acronym	HBDPump 2005
Study objectives	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(s)	The London Research Ethics Committee (REC), 02/02/2006, ref: 05/MRE02/75
Health condition(s) or problem(s) studied	Kidney preservation prior to transplantation
Intervention	Machine perfusion of the kidney before transplantation versus simple cold storage
Intervention type	Procedure/Surgery
Primary outcome measure	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 study start date	28/06/2006
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200
Key inclusion criteria	Patients (aged 18 years and over, either gender) undergoing transplantation of a kidney from a heart-beating cadaver donor.
Key exclusion criteria	Added 24/02/2009: Multi-organ recipient
Date of first enrolment	28/06/2006
Date of final enrolment	30/06/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Addenbrooke's Hospital

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Addenbrooke's Hospital (UK)
Hospital/treatment centre

Hills Road
Cambridge
CB2 2QQ
England
United Kingdom

Website	http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html
"ROR"	https://ror.org/055vbxf86

Funders

Funder type

Hospital/treatment centre

Addenbrooke's Hospital (UK) - transplant research fund

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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