RecruitingNCT05884736

Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant

Confirming the Permanent Cessation of Intracranial Circulation During Abdominal Normothermic Regional Perfusion After the Determination of Death by Circulatory Criteria


Sponsor

Western University, Canada

Enrollment

30 participants

Start Date

Apr 2, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study aims to evaluate the surgical technique used in Abdominal Normothermic Regional Perfusion (A-NRP) in death determination by circulatory criteria (DCC) organ donors. The proposed study will demonstrate that there is no resumption of brain blood flow or activity during the A-NRP procedure. This will be assessed using multimodal neuromonitoring protocol that enables continuous focused monitoring of brain blood flow and activity during A-NRP. This will provide evidence that brain blood flow and activity does not resume during NRP and ensure donor safety in using this technique in standard of care practice.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

  • ≤ 18 years of age

Exclusion Criteria3

  • \< 18 years of age
  • DCC donors who proceed to donation following medical assistance in dying or those who are able to provide first-person consent at the time of donation
  • Injuries that anatomically preclude the use of neurological monitoring

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Interventions

OTHERNeuromonitoring

Multimodal neuromonitoring will include: Transcranial colour-coded Doppler (TCCD), Electroencephalography (EEG), and Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP)


Locations(2)

London Health Sciences Centre

London, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

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NCT05884736


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