Validation of UK protocols to exclude brain blood flow during NRP
Research type
Research Study
Full title
Validation of UK protocols to exclude brain blood flow during Normothermic Regional Perfusion (NRP).
IRAS ID
319131
Contact name
Antonio Rubino
Contact email
Sponsor organisation
Royal Papworth Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Numerous techniques are employed to optimise the number of organs successfully retrieved, one of which is Normothermic Regional Perfusion (NRP). NRP is a surgical technique which uses a specific circuit to return oxygenated blood to selected organs during organ retrieval to optimise their quality and function.
There are two types of NRP- Abdominal NRP (A-NRP) and Thoraco- abdominal NRP (TA-NRP). A-NRP perfuses abdominal organs only, whereas TA-NRP perfuses both abdominal, heart and lung organs facilitated by a slightly different surgical technique. Oxygenated blood must not be perfused to the brain with either technique to satisfy ethical criteria; this is achieved through the use of carefully positioned surgical clamps. Whilst A-NRP is now routine practice in many centres with promising results, concerns about the possibility of resumption of blood flow to the brain in TA-NRP through collateral circulation has greatly impacted the utilisation of this technique.
This study aims to evaluate all patients undergoing NRP services in a single transplant centre, proving that brain blood flow is not resumed during either approach. The study will be conducted in two stages:
-First stage: 5 patients undergoing A-NRP only will be evaluated for brain blood flow using two assessment modalities during organ retrieval surgery:
> CT angiogram of the brain
> Continuous Hb02 readings.-Second stage: Once the results from this stage have been analysed to confirm that no brain blood flow is evident, the study will proceed to assess brain blood flow in 5 patients undergoing TA-NRP.
The study group hypothesise that such assessment methods will provide further supporting evidence to indicate that meaningful brain blood flow is not present during NRP, therefore ethical rationale for this form of donation is maintained. Such findings will promote trust in the use of such novel techniques in routine practice.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
23/EE/0122
Date of REC Opinion
14 Jun 2023
REC opinion
Favourable Opinion