Plain English Summary
Background and study aims
Organs from donors dying following cessation of the circulation suffer excess damage due to being without a supply of oxygen and nutrients for a period before cold storage, a circumstance described as warm ischaemia. Following transplantation this may result in the organs functioning poorly or, occasionally, not at all. We wished to study a new technique to try to overcome this damage, or to enable irreversible damage to be identified before the organs are used.
Who can participate?
Deceased solid organ donors aged 18 to 70 dying on an intensive care unit.
What does the study involve
In order to reverse the initial period of warm ischaemic injury we evaluated a technique of restoring a blood supply to the organs before removal to allow them to recover from ischaemia before cooling them down for package and transport to the recipient. The technique involved using an oxygenator and pump system similar to that used when patients undergo cardiopulmonary bypass surgery, and connecting this to the donor following death. In this way the organs received a supply of oxygenated donor blood at normal body temperature (37°C). Following two hours the organs can then be flushed with cold preservation solution as is the normal practice.
What are the possible benefits and risks of participating?
There are no benefits or risks to the donor, who is dead already. There is a risk that the organs may suffer a complication of the technique, the most likely being a blood clot (thrombosis), but this is prevented by the use of high doses of heparin.
Where is the study run from?
Addenbrookes Hospital (UK).
When is the study starting and how long is it expected to run for?
The study ran from October 2009 to October 2011.
Who is funding the study?
The Evelyn Trust (UK).
Who is the main contact?
Mr Chris Watson
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NRP01
Study information
Scientific title
A non-randomised controlled pilot study of normothermic regional perfusion in organ donors following cardiac death
Acronym
Study hypothesis
Normothermic perfusion will improve the outcome of organs from donors dying following cardiac death and increase the utilisation of organs from each donor.
Ethics approval
Cambridgeshire 3 Research Ethics Committee, 21/09/2009, ref: 09/H0306/72
Study design
Non-randomised controlled single-centre trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Organ transplantation
Intervention
Control arm: cannulae will be placed in the aorta and vena cava and cold Soltran™ preservation solution perfused through the abdominal organs, following which they will be removed. Duration: 30 to 60 minutes.
Intervention arm: Cannulae will be placed into the aorta and vena cava and blood pumped from the vena cava through a extra-corporeal membrane oxygenator back into the aorta to provide regional perfusion of the abdominal organs. After 120 to 240 minutes they will be flushed perfused with cold Soltran™ preservation solution and removed.
The only follow up is in the organ recipients, who will be followed up for 3 months following transplantation.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Number of potential organs used for transplantation
Secondary outcome measures
Measured at 3 months:
1. Measures of function in the first week post-transplantation
2. Graft and patient survival for liver, kidney and pancreas
Overall trial start date
01/10/2009
Overall trial end date
01/10/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Individuals dying on an intensive care unit diagnosed by cardiac criteria and becoming solid organ donors
2. Deceased donors: aged 18 to 70 years, either sex; Recipients: aged 18 to 75 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Time from withdrawal of treatment to death over 2 hours
Recruitment start date
01/10/2009
Recruitment end date
01/10/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Surgery
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust (UK)
Sponsor details
Research and Development Department
Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
The Evelyn 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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24646774
Publication citations
-
Results
Butler AJ, Randle LV, Watson CJ, Normothermic regional perfusion for donation after circulatory death without prior heparinization., Transplantation, 2014, 97, 12, 1272-1278, doi: 10.1097/TP.0000000000000082.