Brain DeathNCT03262896
Neurophysiological Examination in Patients With Brain Death
An observational study of Brain Death, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This study examines muscle movements of elecromyography in adults with brain death. Half of the participants will have brain death, the other half will be healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Death
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2017to 15 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients in the adult intensive care unit
Who may be able to join
- Adult patients with definite diagnosis of brain death,
- Patients with permission from their parents,
- Patients without trauma of medullaspinalis and peripheral nerve injuries,
- Patients without previously known muscle disease (Myasthenia gravis, myopathy, etc.),
- Patients with previously unknown neurological disease (Amyotrophic Lateral Sclerosis, Multiple sclerosis, Guillain Barre syndrome, Poliomyelitis, etc.),
- Patients who have not previous systemic diseases (Connective Tissue Disease, Diabetes mellitus, Chronic renal failure, etc.).
Who cannot join
- Uncertain brain death,
- Patients without permission of family members,
- Younger than 18 years old and older than 72 years,
- Patients with medulla spinalis and peripheral nerve injuries,
- Patients with known muscle disease (Myasthenia gravis, myopathy, etc.),
- Patients with neurological disease (Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Guillain Barre Syndrome, Poliomyelitis, etc.),
- Patients with previous systemic diseases (Connective Tissue Disease, Diabetes, Chronic Kidney Failure, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuzuncu Yil University, School of Medicine
Van, Tusba / Zeve Kampus, 65080
About this study
Official title: Neurophysiological Study in Patients With Brain Death: A Single Center Prospective Study
This study examines muscle movements of elecromyography in adults with brain death. Half of the participants will have brain death, the other half will be healthy volunteers.
Read the detailed description
In some of the patients who have brain death diagnosis, some movements may be seen. Because of these movements, the doctors sometimes avoid to make brain death diagnosis. So making brain death diagnosis may delay. And in these patients, even if the brain death diagnosis made the family members refuse to donate the organs of the patients because they think their patients may survive when they see muscle movements with touch. These patients with brain death are lost in a short time, so some of the patients can not be used as donors. In this study, the investigators aim to raise awareness the movements in brain death patients can be seen, to study the movements neurophysiologically by EMG, whether EMG can be used as auxiliary method or not in brain death diagnosis and to raise organ donation numbers from cadavers. Investigators will examine the motor response and F response in the facial nerve, median nerve, and tibialis posterior nerve with electromyography neurophysiologically.
- Conditions
- Brain Death
- Keywords
- Brain Death, Spinal Reflex, Electromyography
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with brain death | Ten patients with definite etiology, who were diagnosed with brain death because of Apnea test positive and / or cranial reflexes were not available and were male and female patients aged 18-72 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axonal response
Measure of axonal response by electromyography
Measured: Within 72 hours from brain death diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start15 May 2017
- Primary completion15 May 2018
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilmi Demirkiran, MD, Yuzuncu Yil University
- Investigators
- Hilmi Demirkiran, MD, Study director, Department of Anethesiology and ReanimationAydin Cagac, MD, Principal investigator, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262896
- Sponsor's protocol ID
- EMG in Brain Death
- Status last verified
- Oct 2019
- First submitted
- 19 Aug 2017
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Study in Patients With Brain Death: A Single Center Prospective Study
- ClinicalTrials.gov ID
- NCT03262896
- Acronym / sponsor ID
- EMG in Brain Death
- Conditions
- Brain Death
- Keywords
- Brain Death, Spinal Reflex, Electromyography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines muscle movements of elecromyography in adults with brain death. Half of the participants will have brain death, the other half will be healthy volunteers.
Detailed description
In some of the patients who have brain death diagnosis, some movements may be seen. Because of these movements, the doctors sometimes avoid to make brain death diagnosis. So making brain death diagnosis may delay. And in these patients, even if the brain death diagnosis made the family members refuse to donate the organs of the patients because they think their patients may survive when they see muscle movements with touch. These patients with brain death are lost in a short time, so some of the patients can not be used as donors. In this study, the investigators aim to raise awareness the movements in brain death patients can be seen, to study the movements neurophysiologically by EMG, whether EMG can be used as auxiliary method or not in brain death diagnosis and to raise organ donation numbers from cadavers. Investigators will examine the motor response and F response in the facial nerve, median nerve, and tibialis posterior nerve with electromyography neurophysiologically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with brain death | – | –Ten patients with definite etiology, who were diagnosed with brain death because of Apnea test positive and / or cranial reflexes were not available and were male and female patients aged 18-72 years |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the adult intensive care unit
Key inclusion criteria (6 listed)
- Adult patients with definite diagnosis of brain death,
- Patients with permission from their parents,
- Patients without trauma of medullaspinalis and peripheral nerve injuries,
- Patients without previously known muscle disease (Myasthenia gravis, myopathy, etc.),
- Patients with previously unknown neurological disease (Amyotrophic Lateral Sclerosis, Multiple sclerosis, Guillain Barre syndrome, Poliomyelitis, etc.),
Key exclusion criteria (7 listed)
- Uncertain brain death,
- Patients without permission of family members,
- Younger than 18 years old and older than 72 years,
- Patients with medulla spinalis and peripheral nerve injuries,
- Patients with known muscle disease (Myasthenia gravis, myopathy, etc.),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Axonal response
Time frame: Within 72 hours from brain death diagnosis
Measure of axonal response by electromyography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilmi Demirkiran, MD study director
Department of Anethesiology and Reanimation
Aydin Cagac, MD principal investigator
Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Death, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axonal response (time frame: Within 72 hours from brain death diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019; AzTrials last refreshed its copy on 31 Oct 2026.