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NCT Number: NCT05884736

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

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.

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Key information

Conditions

Organ Transplant

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

London Health Sciences Centre, London, Ontario, Canada

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About this study

This will be a multi-centre prospective observational cohort study that will enroll eligible DCC donors at participating donation hospitals. Participating programs will implement the A-NRP processes and organ recovery at the donation sites. Neurocritical care teams and donation physicians at the donation site and independent of transplant teams will implement neuromonitoring using the following modalities:

  • Transcranial colour-coded Doppler (TCCD) as a measure of brain blood flow,
  • Electroencephalography (EEG), as a measure of cortical brain electrophysiologic activity, and
  • Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP), as a measure of brainstem electrophysiologic activity.

The neuromonitoring team will interpret observed signals in real-time during the A-NRP process. This study will confirm whether current A-NRP surgical safeguards ensure maintenance of permanent cessation of brain blood flow and/or activity during A-NRP and will guide the adoption of A-NRP in Ontario.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≤ 18 years of age
  • Potential DCC donors whose families/surrogate decision makers have consented to DCC organ donation according to current criteria of the participating transplant programs. These may include patients donating a liver, kidneys, pancreas, and/or lungs; please see Appendix A for organ specific donor inclusion criteria.

Exclusion criteria

  • < 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

Treatment and study plan

Neuromonitoring

Other

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

Primary outcomes

  1. Donor resumption of brain blood flow and/or activity

    Time frame: Through study completion, an average of 1 year

    Proportion of enrolled patients who have resumption of brain blood flow and/or activity during A-NRP on any neuromonitor and that is confirmed by neurocritical care physician and that results in termination of A-NRP

Secondary outcomes

  1. Donor accrual rate

    Time frame: Through study completion, an average of 1 year

    Number of eligible donors who are enrolled in the study and complete study procedures

  2. Consent rate

    Time frame: Through study completion, an average of 1 year

    Number of donors who consent to study procedures divided by the number of donors approached for study consent (target ≥ 80%)

  3. Neuromonitoring modalities

    Time frame: Through study completion, an average of 1 year

    Number of neuromonitoring modalities used per patient and reasons for excluding specific modalities

  4. Duration and proportion of neuromonitoring signal

    Time frame: Through study completion, an average of 1 year

    Duration of continuous neuromonitoring and proportion of total recording time with adequate signal per patient (velocity waveforms for TCCD, uv/mm for EEG, brainstem auditory evoked potentials (BAEP) signal, and somatosensory evoked potentials (SSEP) signal)

  5. Neuromonitoring failure

    Time frame: Through study completion, an average of 1 year

    Proportion of enrolled patients who had failure of neuromonitoring equipment during recording

Study contacts

Contact information is provided by the study sponsor or research team.

Anton Skaro, MD PhD

CONTACT

[email protected]

519-663-2904

Crystal Engelage, PhD

CONTACT

[email protected]

519-685-8500 ext. 37517

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Collaborators

  • University Health Network, Toronto

Registry information

Official study title

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

Acronym: CONCLUDE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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