Condition category
Surgery
Date applied
01/08/2009
Date assigned
07/10/2009
Last edited
31/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mr Chris Watson

ORCID ID

Contact details

Department of Surgery
Box 202
Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom

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

http://www.cuh.org.uk/research/research_index.html

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

  1. 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.

Additional files

Editorial Notes