Clinical Trial: 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
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
Official 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
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 Summary:
Sponsor: Bioquark Inc.
Current Primary Outcome: Reversal of brain death as noted in clinical examination or EEG [ Time Frame: 15 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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: Same as current
Information By: Bioquark Inc.
Dates:
Date Received: April 6, 2016
Date Started: July 2017
Date Completion: July 2018
Last Updated: November 12, 2016
Last Verified: November 2016