Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant
ConditionOrgan Transplant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorWestern University, Canada
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
≤ 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.
Disqualifiers
< 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
Trial population
Patients in critical care at participating study centers who qualify for DCC organ donation and whose families/surrogate decision makers have consented to DCC organ donation according to current criteria of the participating transplant programs.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Neuromonitoring
Other interventionMultimodal neuromonitoring will include: Transcranial colour-coded Doppler (TCCD), Electroencephalography (EEG), and Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP)
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: DCC Donors1 intervention
Trial outcomes
Primary outcomes
1
Donor resumption of brain blood flow and/or activity
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
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Donor accrual rate
Number of eligible donors who are enrolled in the study and complete study procedures
Time frame
Through study completion, an average of 1 year2
Consent rate
Number of donors who consent to study procedures divided by the number of donors approached for study consent (target ≥ 80%)
Time frame
Through study completion, an average of 1 year3
Neuromonitoring modalities
Number of neuromonitoring modalities used per patient and reasons for excluding specific modalities
Time frame
Through study completion, an average of 1 year4
Duration and proportion of neuromonitoring signal
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)
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Western University, Canada
Lead sponsor
University Health Network, Toronto
Collaborator
Source ClinicalTrials.gov