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

NCT05775263 | Unknown

• 1 other identifier: PO3027
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cerebral Blood Flow

Outcome Measures

Primary Outcomes (1)

• CT angiogram

  Brain blood flow

  30 minutes from establishment of NRP

Secondary Outcomes (1)

• Cerebral oximetry

  Prior to withdrawal of life sustaining treatment to 30 minutes after establishment of NRP

Study Arms (2)

A-NRP

Procedure: CT angiogram

TA-NRP

Procedure: CT angiogram

Interventions

CT angiogram PROCEDURE

CT angiography of the brain 30 minutes from establishment of NRP

A-NRP; TA-NRP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Donation after Circulatory Death (DCD) organ donors

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Central Study Contacts

Antonio Rubino

CONTACT

01223 639574; a.rubino@nhs.net

Thomas Howlett

CONTACT

thomas.howlett@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11