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Clinical Trials/NCT05775263
NCT05775263Not yet recruitingNot Applicable

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

Papworth Hospital NHS Foundation Trust0 sites10 target enrollmentStarted: June 1, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
10
Primary Endpoint
CT angiogram
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

CT angiogram

Time Frame: 30 minutes from establishment of NRP

Brain blood flow

Secondary Outcomes

  • Cerebral oximetry(Prior to withdrawal of life sustaining treatment to 30 minutes after establishment of NRP)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

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