Improving Neurotrauma by Depolarization Inhibition with Combination Therapy (INDICT): A Phase 2 Randomized Trial

Abstract

This report describes Year 1 progress of the Phase 2 randomized INDICT trial to determine the feasibility and efficacy of a tiered intensive care protocol to treat severe TBI based on electrocorticographic monitoring of spreading depolarizations (SD). In this period, the study protocol and consent form were prepared and IRB/HRPO ethical approvals were received. A custom clinical study database was developed using CDEs and was implemented in a secure online platform by QuesGen Systems, Inc.; it was tested, reviewed, and is ready for use. To facilitate and document treatment protocol compliance, bedside software was custom programmed on the CarePath platform developed by Micromed, Inc. Training materials and a manual of procedures were developed for study conduct. Equipment and software were set up and tested and are ready to open enrollment at the lead study site. At the other two study sites there were complications that prevented progress toward establishing subawards and ethical approvals.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2022
Accession Number
AD1194093

Entities

People

  • Jed A Hartings

Organizations

  • University of Cincinnati

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Airway Management
  • Analgesia
  • Anesthesia
  • Blood
  • Blood Flow
  • Brain Injuries
  • Cerebral Edema
  • Cerebrovascular Disorders
  • Combination Therapy
  • Contracts
  • Drug Abuse
  • Epilepsy
  • Health Services
  • Hemorrhage
  • Medical Personnel
  • Therapy

Readers

  • Clinical Trial Research.
  • Neurotrauma and Rehabilitation Medicine.