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

NCT ID: NCT05775263

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-06-01

Brief Summary

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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

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Conditions

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Cerebral Blood Flow

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A-NRP

CT angiogram

Intervention Type PROCEDURE

CT angiography of the brain 30 minutes from establishment of NRP

TA-NRP

CT angiogram

Intervention Type PROCEDURE

CT angiography of the brain 30 minutes from establishment of NRP

Interventions

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CT angiogram

CT angiography of the brain 30 minutes from establishment of NRP

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Antonio Rubino

Role: CONTACT

[email protected]
01223 639574

Thomas Howlett

Role: CONTACT

[email protected]

Other Identifiers

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PO3027

Identifier Type: -

Identifier Source: org_study_id