About this trial
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. 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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Therapeutic Normothermia Group
Treatment groups
Locations
Sponsors and collaborators
London Health Sciences Centre
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborator