Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-01-31
2025-12-31
Brief Summary
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1. Is it feasible to conduct this study? Conducting the trial includes the ability to identify and enroll appropriate participants, implement TN, and collect the required data.
2. Can the Creyos Health platform cognitive assessment tool be used to assess and quantify cognitive outcomes in TBI patients?
Researchers will address the aforementioned questions by looking at the following factors:
1. Identification and enrollment rates of appropriate patients
2. Implementation of the intervention and appropriate data collection while admitted
3. Accurate follow up and continued data collection post-discharge
4. Accessibility and ease of use of the Creyos Health platform cognitive assessment tool
Participants will undergo the following procedure:
1. Admission to the Critical Care Trauma Centre through the trauma service
2. Allocation to the intervention or no intervention group
3. Implementation of the intervention or of usual care for a continuous 72 hours
4. Completion of the Creyos Health platform cognitive assessment tool at 3 and 6 months post-discharge from the Critical Care Trauma Centre
Detailed Description
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This current study aims to assess the feasibility of conducting a single centre randomized controlled trial of TN versus no TN in traumatic brain injury (TBI) patients. Patients will be screened and enrolled through the trauma service in the Critical Care Trauma Centre (CCTC).
Patients who consent to enroll in the study will be randomized 1:1 into either the TN or no TN group. Participants allocated to the TN group will immediately commence targeted temperature management for 72 hours, with 4 hourly temperature checks and interventions as indicated. Participants in the no TN group will proceed with standard of care within CCTC. Both groups will be followed at 3 and 6 months post-discharge with cognitive assessments via the Creyos Health platform.
The trial will allow the research team to assess appropriate participant identification and enrollment rates, ease and limitations of intervention implementation, data collection, and post-discharge follow up. The research team will also assess the accessibility and ease of use of the Creyos Health platform in this patient population. In depth primary and secondary outcome measures are outlined elsewhere in the application.
This feasibility trial will be the first step in potentially introducing an evidence based intervention that directly targets cognitive outcomes in the TBI patient population group.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Therapeutic Normothermia Group
Participants randomized to this group will be placed under a targeted temperature model aiming for normothermia for 72 hours. Temperature and interventions will be monitored every 4 hours for the entirety of the 24 hours. Participants will be followed post-discharge and will undergo cognitive assessments at 3 and 6 months.
Therapeutic Normothermia Group
Maintenance of a body temperature between 35 and 37 degrees Celsius using conservative and pharmacological interventions for 72 hours.
Control Group
Participants randomized to this group will undergo usual care in the Critical Care Trauma Centre. Temperature will be monitored as per standard of care. Participants will be followed post-discharge and will undergo cognitive assessments at 3 and 6 months.
No interventions assigned to this group
Interventions
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Therapeutic Normothermia Group
Maintenance of a body temperature between 35 and 37 degrees Celsius using conservative and pharmacological interventions for 72 hours.
Eligibility Criteria
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Inclusion Criteria
* A Glasgow Coma Scale (GCS) of 5-12, inclusive, prior to intubation.
Exclusion Criteria
* Patients not expected to survive 48 hours.
* \>24 hours from injury at time of enrollment.
18 Years
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
London Health Sciences Centre
OTHER
Responsible Party
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Ian Ball
Dr.
Principal Investigators
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Ian Ball, MD
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre
Central Contacts
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References
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Oshorov A, Baranich A, Polupan A, Sychev A, Savin I, Potapov A. Effects of Hyperthermia on Intracranial Pressure and Cerebral Autoregulation in Patients with an Acute Brain Injury. Acta Neurochir Suppl. 2021;131:71-74. doi: 10.1007/978-3-030-59436-7_15.
Hong JM, Choi ES, Park SY. Selective Brain Cooling: A New Horizon of Neuroprotection. Front Neurol. 2022 Jun 20;13:873165. doi: 10.3389/fneur.2022.873165. eCollection 2022.
Oshorov AV, Polupan AA, Sychev AA, Baranich AI, Kurdyumova NV, Abramov TA, Savin IA, Potapov AA. [Influence of cerebral hyperthermia on intracranial pressure and autoregulation of cerebral circulation in patients with acute brain injury]. Zh Vopr Neirokhir Im N N Burdenko. 2021;85(1):68-77. doi: 10.17116/neiro20218501168. Russian.
Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Aneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Kober L, Langorgen J, Lilja G, Moller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. Targeted temperature management at 33 degrees C versus 36 degrees C after cardiac arrest. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.
Rosli D, Schnuriger B, Candinas D, Haltmeier T. The Impact of Accidental Hypothermia on Mortality in Trauma Patients Overall and Patients with Traumatic Brain Injury Specifically: A Systematic Review and Meta-Analysis. World J Surg. 2020 Dec;44(12):4106-4117. doi: 10.1007/s00268-020-05750-5. Epub 2020 Aug 28.
Other Identifiers
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14097
Identifier Type: -
Identifier Source: org_study_id