Clincosm LogoSign in Get a demo

Methods of Confirmation of Brain Death

Sponsor
Brno University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04734574
Collaborator
(none)
60
Enrollment
1
Location
6
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to describe the use of methods confirming brain death in the real clinical practice of the transplant program in the Czech Republic.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Organ donation is possible in the Czech Republic only after meeting the legislative requirements. These require confirmation of brain death by one of the statutory methods before organ harvesting. The use of these methods in clinical practice has not yet been described.The aim of this retrospective observational study is to describe the use of these methods in the real clinical practice of the transplant program in the Czech Republic, taking into account the legislation of other European countries.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Use of Different Methods of Confirmation of Brain Death in Brain Death Donors
    Actual Study Start Date :
    Apr 1, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Angiography [within 24 hours after the onset of signs of brain death]

      Cerebral panangiography

    2. Brainstem auditory evoked potentials [within 24 hours after the onset of signs of brain death]

      Brainstem auditory evoked potentials

    3. Brain scintigraphy [within 24 hours after the onset of signs of brain death]

      Brain scintigraphy

    4. Cerebral computed tomography angiography [within 24 hours after the onset of signs of brain death]

      Cerebral computed tomography angiography

    5. Transcranial Doppler ultrasonography [within 24 hours after the onset of signs of brain death]

      Transcranial Doppler ultrasonography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • age ≥18 years

    • organ donor

    Exclusion Criteria:
    • age under 18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Brno Brno Czechia 62500

    Sponsors and Collaborators

    • Brno University Hospital

    Investigators

    • Study Chair: Roman Gal, M.D., Ph.D., University Hospital Brno

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ondrej Hrdy, Principal Investigator, Brno University Hospital
    ClinicalTrials.gov Identifier:
    NCT04734574
    Other Study ID Numbers:
    • CT0022020
    First Posted:
    Feb 2, 2021
    Last Update Posted:
    May 6, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Death
    Death

    Study Results

    No Results Posted as of May 6, 2022