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Clinical Trials/NCT03262896
NCT03262896
Completed
N/A

Neurophysiological Study in Patients With Brain Death: A Single Center Prospective Study

Yuzuncu Yıl University1 site in 1 country10 target enrollmentMay 15, 2017
ConditionsBrain Death

Overview

Phase
N/A
Intervention
Not specified
Conditions
Brain Death
Sponsor
Yuzuncu Yıl University
Enrollment
10
Locations
1
Primary Endpoint
Axonal response
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2017
End Date
September 15, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Yuzuncu Yıl University
Responsible Party
Principal Investigator
Principal Investigator

Hilmi Demirkiran, MD

Assistant Professor

Yuzuncu Yıl University

Eligibility 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.)

Outcomes

Primary Outcomes

Axonal response

Time Frame: Within 72 hours from brain death diagnosis

Measure of axonal response by electromyography

Study Sites (1)

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