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Could a 5-Day chill save brains after severe trauma?

NCT ID NCT01886222

Disease control Sponsor: RenJi Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether deliberately cooling the body to 34-35°C for five days after a severe traumatic brain injury improves neurological recovery at six months, compared with standard care that keeps temperature normal. Adults aged 18-65 with a closed head injury and high pressure inside the skull are randomly assigned to either mild hypothermia or normothermia. The goal is to see if the cooling strategy reduces death and severe disability and improves the chance of a meaningful recovery.

What this could mean

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

Active substance
Long-term mild hypothermia (cooling the body to 34-35°C for 5 days)
What this could lead to
If cooling the brain soon after a severe injury improves recovery, it could become a standard early treatment to reduce long-term disability and death.
What could go wrong
This is a mid-stage trial, and cooling may not improve outcomes. It also carries risks like infection or heart rhythm problems, and results may not apply to all patients.

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

312 people

The number who actually took part.

Started

Nov 2013

Finished

Jun 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 65 years

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: * Age 18 - 65 years within 6 hours post injury; * Closed head injury; * Glasgow Coma Scale(GCS) score 4 to 8 after resuscitation; * The intracranial pressure is more than 25 mmHg; * Cerebral contusion on computed tomographic scan. Exclusion Criteria: * GCS of 3 with bilateral fixed and dilated pupils; * A life-threatening injury to an organ other than the brain; * No spontaneous breathing or cardiac arrest at the scene of the injury; * No consent; * Pregnancy.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic brain injury Craniocerebral Trauma traumatic brain injury

As listed by the trial registrant

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

Brain injuries Craniocerebral trauma

Contacts and locations

Locations

  • Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200127, China

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