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Therapeutic Normothermia in TBI

ConditionTraumatic Brain Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Therapeutic Normothermia Group

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Therapeutic Normothermia GroupActive comparator 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
18 months
2

Creyos Health

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

Time frame
12 months

Secondary outcomes

1

Mortality

To assess any differences in in-hospital mortality between the two study groups.

Time frame
12 months.
2

Cognitive Outcomes

To assess any differences in cognitive outcomes between the two study groups.

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

London Health Sciences Centre

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: