Therapeutic Normothermia in TBI (MAMBA-FT)

December 11, 2024 updated by: Ian Ball, London Health Sciences Centre

Therapeutic Normothermia in the Treatment of Traumatic Brain Injury Trial: Feasibility 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Therapeutic normothermia (TN) is globally accepted as standard of care in post-cardiac arrest patients to maximize neurologic recovery. Both hypothermia and normothermia have been trialed and were noted to prevent the harmful effects of hyperthermia on intracranial pressures and the cardiovascular system. Normothermia is favored for its improved cardiovascular, hematological, immunological, and metabolic outcomes. In trauma patients specifically, hypothermia (whether therapeutic or accidental) has been shown to result in worse outcomes and increased mortality. Despite this, therapeutic normothermia has never been purposely applied as a primary intervention in TBI patients.

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hana Geres, MB BCh BAO
  • Phone Number: 6477747081
  • Email: hgeres@uwo.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Therapeutic Normothermia Group
Maintenance of a body temperature between 35 and 37 degrees Celsius using conservative and pharmacological interventions for 72 hours.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Execution
Time Frame: 18 months
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
Time Frame: 12 months
To assess the feasibility of using the Creyos Health platform as a cognitive assessment tool in patients with TBI.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 12 months.
To assess any differences in in-hospital mortality between the two study groups.
12 months.
Cognitive Outcomes
Time Frame: 12 months
To assess any differences in cognitive outcomes between the two study groups.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London Health Sciences Centre

Collaborators

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

Investigators

  • Principal Investigator: Ian Ball, MD, London Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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