NCT03176823

Remote Ischemic Conditioning as a Treatment for Traumatic Brain Injury

Completed NA Last updated 15 March 2024

What this trial tests

NA trial testing CellAegis Technologies autoRIC device in Traumatic Brain Injury in 44 participants. Completed in 3 March 2024.

Timeline

3 May 2019

Primary endpoint
1 November 2023

3 March 2024

Quick facts

Lead sponsor	Unity Health Toronto
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	44
Start date	3 May 2019
Primary completion	1 November 2023
Estimated completion	3 March 2024
Sites	1 location across Canada

Drugs / interventions tested

• CellAegis Technologies autoRIC device
• Best Practice Management of Traumatic Brain Injury

Conditions studied

• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
• Trauma, Nervous System — all drugs for Trauma, Nervous System →
• Reperfusion Injury — all drugs for Reperfusion Injury →
• Ischemia, Brain — all drugs for Ischemia, Brain →

Sponsor

Unity Health Toronto — full company profile →

Who can join

18 and older, any sex, with Traumatic Brain Injury or Trauma, Nervous System. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The prevention of secondary brain injury is a primary goal in treating patients with severe traumatic brain injury (TBI). Secondary brain injury results from tissue ischemia induced by increased vascular resistance in the at-risk brain tissue due to compression by traumatic hematomas, and development of cytotoxic and vasogenic tissue edema. While traumatic hematomas may be managed surgically, cytotoxic and vasogenic edema with resulting perfusion impairment perpetuates brain ischemia and injury. Animal models suggest that remote ischemic conditioning (RIC) can reverse these effects and improve perfusion. Based on these findings it is hypothesized that RIC will exert beneficial effects on TBI in man, thereby representing a new therapeutic strategy for severe TBI.

Patients presenting to our institution suffering from severe TBI will be considered for enrollment. Eligible patients will have sustained a blunt, severe TBI (defined by Glasgow Coma Scale \<8) with associated intra-cranial hematoma(s) not requiring immediate surgical decompression, with admission to an intensive care unit and insertion of an intra-cranial pressure monitor. Patients will be randomized to RIC versus sham-RIC intervention cohorts. RIC interventions will be performed using an automated device on the upper extremity delivering 20 cumulative minutes of limb ischemia in a single treatment session. The planned enrollment is a cohort of 40 patients.

Outcomes of this study will include multiple domains. Our primary outcome will include serial assessments of validated serum biomarkers of neuronal injury and systemic inflammation. Secondary outcomes will include descriptions of the clinical course of each patient, radiologic assessment of brain perfusion, and neurocognitive and psychological assessment post-discharge.

If clinical outcomes are improved using RIC, this study would support RIC as a novel treatment for TBI. Its advantages include safety and simplicity and, requiring no specialized equipment, its ability to be used in any environment including pre-hospital settings or in austere theatres. The investigators anticipate that TBI patients treated with RIC will have improved clinical, biochemical, and neuropsychological outcomes compared to standard treatment protocols.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advances in development of biomarkers for brain damage and ischemia.
   Karimova D, Rostami E, Chubarev VN, Tarasov VV, et al · · 2024 · cited 5× · PMID 39001884 · DOI 10.1007/s11033-024-09708-x