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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05775263
Enrollment
10
Registered
2023-03-20
Start date
2024-06-01
Completion date
2025-06-01
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Blood Flow

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.

Interventions

PROCEDURECT angiogram

CT angiography of the brain 30 minutes from establishment of NRP

Sponsors

Cambridge University Hospitals NHS Foundation Trust
CollaboratorOTHER
Papworth Hospital NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
CT angiogram30 minutes from establishment of NRPBrain blood flow

Secondary

MeasureTime frameDescription
Cerebral oximetryPrior to withdrawal of life sustaining treatment to 30 minutes after establishment of NRPHbO2 measurements (O2Hbi (Delta oxygenated), HHbi (Delta deoxygenated), and cHbi (Delta total))

Contacts

Primary ContactAntonio Rubino
a.rubino@nhs.net01223 639574
Backup ContactThomas Howlett
thomas.howlett@nhs.net

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026