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

• Sponsor: Papworth Hospital NHS Foundation Trust (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05775263
• Collaborator: Cambridge University Hospitals NHS Foundation Trust (Other)
• Enrollment: 10
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Normothermic Regional Perfusion	Procedure: CT angiogram

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Validation of UK Protocols to Exclude Brain Blood Flow During Normothermic Regional Perfusion (NRP)
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. CT angiogram [30 minutes from establishment of NRP]

   Brain blood flow

Secondary Outcome Measures

1. 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))

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Papworth Hospital NHS Foundation Trust
• Cambridge University Hospitals NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Papworth Hospital NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT05775263
• Other Study ID Numbers: PO3027
• First Posted: Mar 20, 2023
• Last Update Posted: Mar 20, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 20, 2023