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Neurophysiological Examination in Patients With Brain Death

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ClinicalTrials.gov Identifier: NCT03262896
Recruitment Status : Active, not recruiting
First Posted : August 25, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Hilmi Demirkiran, MD, Yuzuncu Yıl University

Brief 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.

Condition or disease
Brain Death

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurophysiological Study in Patients With Brain Death: A Single Center Prospective Study
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : May 15, 2018
Estimated Study Completion Date : December 15, 2018

Group/Cohort
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



Primary Outcome Measures :
  1. Axonal response [ Time Frame: Within 72 hours from brain death diagnosis ]
    Measure of axonal response by electromyography



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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients in the adult intensive care unit
Criteria

Inclusion Criteria:

  • 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.).

Exclusion Criteria:

  • 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262896


Locations
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Turkey
Yuzuncu Yil University, School of Medicine
Van, Tusba / Zeve Kampus, Turkey, 65080
Sponsors and Collaborators
Yuzuncu Yıl University
Investigators
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Study Director: Hilmi Demirkiran, MD Department of Anethesiology and Reanimation
Principal Investigator: Aydin Cagac, MD Department of Neurology

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Responsible Party: Hilmi Demirkiran, MD, Assistant Professor, Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT03262896     History of Changes
Other Study ID Numbers: EMG in Brain Death
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hilmi Demirkiran, MD, Yuzuncu Yıl University:
Brain Death
Spinal Reflex
Electromyography

Additional relevant MeSH terms:
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Death
Brain Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations