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

Not yet recruiting

• Conditions: Cerebral Blood Flow
• Interventions: Procedure: CT angiogram

• Registration Number: NCT05775263
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Study Start: 2024-06-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A-NRP	CT angiogram	-
TA-NRP	CT angiogram	-

Primary Outcome Measures

Name	Time	Method
CT angiogram	30 minutes from establishment of NRP	Brain blood flow

Secondary Outcome Measures

Name	Time	Method
Cerebral oximetry	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))