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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02742857
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : October 1, 2020
Sponsor:
Collaborators:
Revita Life Sciences
Anupam Hospital
Information provided by (Responsible Party):
Bioquark Inc.

Tracking Information
First Submitted Date  ICMJE April 6, 2016
First Posted Date  ICMJE April 19, 2016
Last Update Posted Date October 1, 2020
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
Reversal of brain death as noted in clinical examination or EEG [ Time Frame: 15 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
  • 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
  • MRI analysis to analyze any changes in meninges [ Time Frame: 15 days ]
    To signify any signs of aseptic or bacterial meningitis
  • Pulse [ Time Frame: 15 days ]
  • O2 saturation [ Time Frame: 15 days ]
  • Blood Pressure [ Time Frame: 15 days ]
  • Respiration changes [ Time Frame: 15 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Brain Death
Intervention  ICMJE
  • Biological: BQ-A Peptide Extract
    BQ-A Peptide Extract
  • Biological: Mesenchymal Stem Cells
    Mesenchymal Stem Cells
  • Device: Transcranial Laser Therapy
    Transcranial Laser Therapy
  • Device: Median Nerve Stimulator
    Median Nerve Stimulator
Study Arms  ICMJE Experimental: Treatment Group
Interventions:
  • Biological: BQ-A Peptide Extract
  • Biological: Mesenchymal Stem Cells
  • Device: Transcranial Laser Therapy
  • Device: Median Nerve Stimulator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2020
Actual Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02742857
Other Study ID Numbers  ICMJE BQ12016
AAH -01-2016 ( Other Identifier: Anupam Hospital )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Bioquark Inc.
Study Sponsor  ICMJE Bioquark Inc.
Collaborators  ICMJE
  • Revita Life Sciences
  • Anupam Hospital
Investigators  ICMJE
Principal Investigator: Himanshu Bansal, MD Revita Life Sciences
PRS Account Bioquark Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP