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Brain Temperature-Guided cooling may improve fever control in severe brain injury

NCT ID NCT03967626

Disease control Sponsor: Fondation Ophtalmologique Adolphe de Rothschild Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether cooling the brain based on its own temperature, rather than body temperature, improves fever control in severe brain injury patients. 41 adults with brain injury and fever were enrolled. The intervention group used an external cooling device guided by brain temperature, while the control group used body temperature guidance. The main goal was to see how often brain temperature stayed within the target range (36-37°C).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
external cooling device (Artic Sun)
What this could lead to
If successful, this could lead to better fever management in brain-injured patients, potentially reducing brain damage.
What could go wrong
This is a small, completed study with only 41 participants. The results may not apply to all brain injury patients, and the approach requires specialized brain temperature monitoring not widely available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

41 people

The number who actually took part.

Started

Nov 2019

Finished

Apr 2024

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * patients 18 years of age or older * hospitalized patient in neuro-resuscitation with peak monitoring with cerebral temperature measurement by an intra-parenchymal sensor (Sophysa®) * patient in hyperthermia (TC ≥ 38.5 °c) and in a situation of brain pain Exclusion Criteria: * patient benefiting from a legal protection measure * pregnant or breastfeeding woman * previous participation in this study

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Conditions

The condition(s) this trial relates to.

brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain injuries

Contacts and locations

Locations

  • Hôpital Fondation Adolphe Rothschild

    Paris, 75019, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.