Therapeutic Normothermia in TBI

NCT06540768 | Not Yet Recruiting

• 1 other identifier: 14097
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This feasibility trial is the first step in testing the hypothesis that maintenance of normal body temperature, called therapeutic normothermia (TN), for 72 continuous hours in traumatic brain injury (TBI) patients can improve cognitive function. The trial aims to answer the following questions:

1. 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. 2.Can the Creyos Health platform cognitive assessment tool be used to assess and quantify cognitive outcomes in TBI patients?
3. 3.Identification and enrollment rates of appropriate patients
4. 4.Implementation of the intervention and appropriate data collection while admitted
5. 5.Accurate follow up and continued data collection post-discharge
6. 6.Accessibility and ease of use of the Creyos Health platform cognitive assessment tool
7. 7.Admission to the Critical Care Trauma Centre through the trauma service
8. 8.Allocation to the intervention or no intervention group
9. 9.Implementation of the intervention or of usual care for a continuous 72 hours
10. 10.Completion of the Creyos Health platform cognitive assessment tool at 3 and 6 months post-discharge from the Critical Care Trauma Centre

Conditions

Traumatic Brain Injury

Keywords

TBI; therapeutic normothermia; targeted temperature management; cognitive outcomes; traumatic brain injury

Outcome Measures

Primary Outcomes (2)

• Study Execution

  To assess the feasibility of conducting a randomized controlled trial of therapeutic normothermia compared to no therapeutic normothermia in LHSC patients with TBI.

  18 months

• Creyos Health

  To assess the feasibility of using the Creyos Health platform as a cognitive assessment tool in patients with TBI.

  12 months

Secondary Outcomes (2)

• Mortality

  12 months.

• Cognitive Outcomes

  12 months

Study Arms (2)

Therapeutic Normothermia Group

ACTIVE COMPARATOR

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.

Other: Therapeutic Normothermia Group

Control Group

NO INTERVENTION

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.

Interventions

Therapeutic Normothermia Group OTHER

Maintenance of a body temperature between 35 and 37 degrees Celsius using conservative and pharmacological interventions for 72 hours.

Therapeutic Normothermia Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>= 18 years of age) who present through the LHSC trauma service and have sustained a TBI.
• A Glasgow Coma Scale (GCS) of 5-12, inclusive, prior to intubation.

You may not qualify if:

• GCS at time of presentation of 4 or less or 13 or more.
• Patients not expected to survive 48 hours.
• \>24 hours from injury at time of enrollment.

Sponsors & Collaborators

• London Health Sciences Centre: lead
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

Related Publications (5)

• 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.

  PMID: 33839821 BACKGROUND

• 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.

  PMID: 35795804 BACKGROUND

• 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.

  PMID: 33560622 BACKGROUND

• 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.

  PMID: 24237006 BACKGROUND

• 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.

  PMID: 32860141 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ian Ball, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hana Geres, MB BCh BAO

CONTACT

6477747081; hgeres@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Single center unblinded randomized controlled trial

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share