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Traumatic Brain InjuryMAMBA-FTNCT06540768

Therapeutic Normothermia in TBI

A study testing Therapeutic Normothermia Group in people with Traumatic Brain Injury, run by London Health Sciences Centre.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Therapeutic Normothermia Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Jan 2025to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hana Geres, MB BCh BAO contact

6477747081

hgeres@uwo.ca

About this study

Official title: 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?
Read more

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
Read the 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.

Being tested
Therapeutic Normothermia Group
Keywords
TBI, therapeutic normothermia, targeted temperature management, cognitive outcomes, traumatic brain injury
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic Normothermia GroupOther

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

Study groups in NCT06540768
Study groupRoleWhat they receive
Therapeutic Normothermia GroupActive comparatorParticipants 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.
Receives: Other: Therapeutic Normothermia Group
Control GroupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18 months

  2. Creyos Health

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

    Measured: 12 months

Secondary outcomes (2)

  1. Mortality

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

    Measured: 12 months.

  2. Cognitive Outcomes

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study startJan 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single center unblinded randomized controlled trial
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06540768
Sponsor's protocol ID
14097
Acronym
MAMBA-FT
Status last verified
Dec 2024
First submitted
2 Aug 2024
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33839821

  • 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.

    PubMed 35795804

  • 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.

    PubMed 33560622

  • 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.

    PubMed 24237006

  • 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.

    PubMed 32860141

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic Normothermia Group in people with Traumatic Brain Injury, run by London Health Sciences Centre.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hana Geres, MB BCh BAO (6477747081, hgeres@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Execution (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06540768, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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