NCT03262896

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 15, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

August 19, 2017

Last Update Submit

October 8, 2019

Conditions

Keywords

Brain DeathSpinal ReflexElectromyography

Outcome Measures

Primary Outcomes (1)

  • Axonal response

    Measure of axonal response by electromyography

    Within 72 hours from brain death diagnosis

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the adult intensive care unit

You may qualify if:

  • 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.).

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University, School of Medicine

Van, Tusba / Zeve Kampus, 65080, Turkey (Türkiye)

Location

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

  • Hilmi Demirkiran, MD

    Department of Anethesiology and Reanimation

    STUDY DIRECTOR
  • Aydin Cagac, MD

    Department of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 19, 2017

First Posted

August 25, 2017

Study Start

May 15, 2017

Primary Completion

May 15, 2018

Study Completion

September 15, 2019

Last Updated

October 10, 2019

Record last verified: 2019-10

Locations