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OpenTrials
Completed

NCT Number: NCT02742857

Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury

This is the proof of concept study with multi-modality approach (using intra-thecal bioactive peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal injury to document possibility of reversal of brain death (BD).

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Key information

Conditions

Brain Death Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Unconsciousness

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anupam Hospital

Rudrapur, Uttarakhand, 263153, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals declared Brain dead from a traumatic brain injury having diffuse axonal injury on MRI
  • Not willing for organ donation
  • Written informed consent from the legally acceptable representative of the patient

Exclusion criteria

  • Metallic clips/ metal implants or intracranial implants in the brain.
  • Pregnancy

Treatment and study plan

BQ-A Peptide Extract

Biological

BQ-A Peptide Extract

Mesenchymal stem cells

Biological

Mesenchymal Stem Cells

Transcranial Laser Therapy

Device

Transcranial Laser Therapy

Median Nerve Stimulator

Device

Median Nerve Stimulator

Primary outcomes

  1. Reversal of brain death as noted in clinical examination or EEG

    Time frame: 15 days

Secondary outcomes

  1. Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation

    Time frame: 15 days

    To signify any signs of aseptic or bacterial meningitis

  2. MRI analysis to analyze any changes in meninges

    Time frame: 15 days

    To signify any signs of aseptic or bacterial meningitis

  3. Pulse

    Time frame: 15 days

  4. O2 saturation

    Time frame: 15 days

  5. Blood Pressure

    Time frame: 15 days

  6. Respiration changes

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Bioquark Inc.

Industry

Collaborators

  • Anupam Hospital
  • Revita Life Sciences

Registry information

Official study title

Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multimodality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 19, 2016
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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