A study of a new technique for organ preservation
| ISRCTN | ISRCTN89667087 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89667087 |
| Secondary identifying numbers | NRP01 |
- Submission date
- 01/08/2009
- Registration date
- 07/10/2009
- Last edited
- 31/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Department of Surgery
Box 202
Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom
Study information
| Study design | Non-randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | A non-randomised controlled pilot study of normothermic regional perfusion in organ donors following cardiac death |
| Study objectives | 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(s) | Cambridgeshire 3 Research Ethics Committee, 21/09/2009, ref: 09/H0306/72 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/2009 |
| Completion date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key exclusion criteria | Time from withdrawal of treatment to death over 2 hours |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 01/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CB2 0QQ
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Department
Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Website | http://www.cuh.org.uk/research/research_index.html |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Charity
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/06/2014 | Yes | No |
