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Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)

ConditionTraumatic Brain Injury
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Cincinnati

About this trial

This study is a randomized Phase 2 trial to determine the feasibility of real-time electrocorticographic monitoring of spreading depolarizations (SD) to guide implementation of a tier-based protocol of intensive care therapies, aimed at SD suppression, for the management of patients who have undergone acute operative treatment of severe traumatic brain injury.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

persistent bilateral non-reactive pupils or other evidence of non-survivable injury,

decompressive craniectomy to treat refractory ICP subsequent to diffuse injury, (3) co-enrollment in another therapeutic TBI trial, and

Trial design

Design model

Parallel

Treatments tested in this trial

  • Full-band Electrocorticography

    Diagnostic test

    Diagnosis of spreading depolarizations in continuous electrocorticography

  • Treatment Algorithm

    Combination product

    Protocol for escalation and de-escalation of physiologic-targeted and pharmacologic therapies to treat and prevent spreading depolarizations

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: SD-Guided CareExperimental treatment 2 interventions
Group B: Standard ICU CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Burden of spreading depolarizations

Spreading depolarization events will be scored based on review of electrocorticographic recordings. The number of depolarizations per recording day over the period of monitoring will serve as the measure of total burden. The burdens computed for patients will be compared between the two randomization arms.

Time frame
During the period of intensive care invasive monitoring, up to two weeks after injury

Secondary outcomes

1

Burden of elevated intracranial pressure

The time integral of the continuously monitored intracranial pressure signal above 22 mmHg will be computed for each patient as the measure of burden. The burdens computed for patients will be compared between the two randomization arms.

Time frame
During the period of intensive care invasive monitoring, up to two weeks after injury
2

Burden of cerebral hypoxia

The time integral of the continuously monitored cerebral oxygenation below 20 mmHg will be computed for each patient as the measure of burden. The burdens computed for patients will be compared between the two randomization arms.

Time frame
During the period of intensive care invasive monitoring, up to two weeks after injury
3

Burden of low cerebral perfusion

The time integral of the continuously monitored cerebral perfusions pressure below 60 mmHg will be computed for each patient as the measure of burden. The burdens computed for patients will be compared between the two randomization arms.

Time frame
During the period of intensive care invasive monitoring, up to two weeks after injury
4

Glasgow Outcome Score-Extended

Scores on the GOS-E will be compared between the two randomization arms

Time frame
6 months post-injury

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cincinnati

Lead sponsor

University of New Mexico

Collaborator

University of Pennsylvania

Collaborator

Source ClinicalTrials.gov
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