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NCT05775263 Clinical Trial

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

Cerebral Blood Flow Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05775263
Other study ID # PO3027
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date June 1, 2025

Study information
Verified date November 2023
Source Papworth Hospital NHS Foundation Trust
Contact Antonio Rubino
Phone 01223 639574
Email a.rubino@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date June 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• CT angiogram
CT angiography of the brain 30 minutes from establishment of NRP

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Papworth Hospital NHS Foundation Trust Cambridge University Hospitals NHS Foundation Trust

Outcome
Type Measure Description Time frame Safety issue
Primary CT angiogram Brain blood flow 30 minutes from establishment of NRP
Secondary Cerebral oximetry 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
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