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Therapeutic Normothermia in TBI

NCT06540768 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-12-16

No results posted yet for this study

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. 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

Conditions

Interventions

OTHER

Therapeutic Normothermia Group

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

Sponsors & Collaborators

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

    collaborator OTHER

  • London Health Sciences Centre

    lead OTHER

Principal Investigators

  • Ian Ball, MD · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06540768 on ClinicalTrials.gov