Validation of UK Protocols to Exclude Brain Blood Flow During Normothermic Regional Perfusion (NRP)

November 27, 2023 updated by: Papworth Hospital NHS Foundation Trust
This study aims to evaluate both Abdominal Normothermic Regional Perfusion (A-NRP) and Thoracoabdominal-NRP (TA-NRP) techniques, proving that brain blood flow is not resumed during NRP. This will be assessed through the use of two modalities: CT angiogram of the brain and continuous Hb02 readings. The study group hypothesise that such assessment methods will provide evidence to indicate that brain blood flow is not present during NRP and promote trust in the use of such novel techniques in routine practice.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Donation after Circulatory Death (DCD) organ donors

Description

Inclusion Criteria:

  • DCD donors in Cambridge University Hospital
  • Planned A-NRP
  • Consent for study has been obtained
  • Those who meet the appropriate criteria for DCD donation following WOLST
  • ≥ 18 years of age
  • ≤ 75 years of age

Exclusion Criteria:

  • DBD organ donors
  • DCD organ donations outside of Cambridge University Hospital
  • DCD donors without planned A-NRP
  • DCD donors whose family have withheld consent for brain blood flow investigations.
  • Patients who do not meet the appropriate criteria for DCD donation following WOLST
  • Patients with injuries that will physically prevent use of the necessary assessment methods

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A-NRP
Procedure: CT angiogram
CT angiography of the brain 30 minutes from establishment of NRP
TA-NRP
Procedure: CT angiogram
CT angiography of the brain 30 minutes from establishment of NRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CT angiogram
Time Frame: 30 minutes from establishment of NRP
Brain blood flow
30 minutes from establishment of NRP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral oximetry
Time Frame: Prior to withdrawal of life sustaining treatment to 30 minutes after establishment of NRP
HbO2 measurements (O2Hbi (Delta oxygenated), HHbi (Delta deoxygenated), and cHbi (Delta total))
Prior to withdrawal of life sustaining treatment to 30 minutes after establishment of NRP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papworth Hospital NHS Foundation Trust

Collaborators

Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • PO3027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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