NCT04734574

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

January 26, 2021

Last Update Submit

March 27, 2023

Conditions

Brain DeathOrgan Donation

Outcome Measures

Primary Outcomes (5)

  • Angiography

    Cerebral panangiography

    within 24 hours after the onset of signs of brain death

  • Brainstem auditory evoked potentials

    Brainstem auditory evoked potentials

    within 24 hours after the onset of signs of brain death

  • Brain scintigraphy

    Brain scintigraphy

    within 24 hours after the onset of signs of brain death

  • Cerebral computed tomography angiography

    Cerebral computed tomography angiography

    within 24 hours after the onset of signs of brain death

  • Transcranial Doppler ultrasonography

    Transcranial Doppler ultrasonography

    within 24 hours after the onset of signs of brain death

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult critically ill patinets with confirmed brain death admitted to university hospital who become brain death organ donor.

You may qualify if:

  • age ≥18 years
  • organ donor

You may not qualify if:

  • age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Brno

Brno, 62500, Czechia

RECRUITING

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roman Gal, M.D., Ph.D.

    University Hospital Brno

    STUDY CHAIR

Central Study Contacts

Ondrej Hrdy, M.D.

CONTACT

532233850hrdy.ondrej@fnbrno.cz

Jaroslav Duba, M.D.

CONTACT

532233850duba.jarosalv@fnbrno.cz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 2, 2021

Study Start

April 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 30, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)