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Chilling the brain during stroke: could cold saline boost recovery?

NCT ID NCT07232082

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether cooling the brain with cold saline during clot-removal surgery helps people recover from severe strokes. About 322 adults with large strokes will be randomly assigned to get standard care or standard care plus local brain cooling. The main goal is to see if more patients are independent at 90 days after treatment.

What this could mean

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

Active substance
intra-arterial cold saline infusion
What this could lead to
If it works, this could offer a new way to protect the brain during stroke treatment, potentially leading to better recovery for patients with large strokes.
What could go wrong
This is an early-stage trial with only 322 participants, so results may not apply to everyone. The cooling procedure carries risks like infection or vessel damage, and it may not improve outcomes.

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

About 322 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

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 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: General Inclusion Criteria: 1. Age ≥18 years old. 2. The National Institutes of Health Stroke Scale (NIHSS) score was ≥6 points before randomization. 3. Time from symptom onset to randomization ≤24h. 4. Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent, and are capable of receiving clinical follow-up. Specific Neuroimaging Inclusion Criteria 1. Prior to randomization, CTA, MRA, or DSA confirmed the presence of anterior circulatory large vessel occlusion (internal carotid artery or M1segment). 2. NCCT ASPECTS value of 3 to 5 based on findings from non-contrast CT within 24 hours after stroke onset (defined as the time the patient was last known to be well), with no limitation with respect to infarct-core volume; 3. NCCT ASPECTS value of 0 to 2 based on findings from non-contrast CT within 24 hours after stroke onset and an infarct-core volume between 70 ml and 100 ml; 4. NCCT ASPECTS value greater than 5 based on findings from non-contrast CT after stroke onset and an infarct-core volume of 70 to 100 ml. Exclusion Criteria: 1. Pre stroke mRS\>1 score. 2. Multivessel Occlusion 3. Concomitant untreated intracranial aneurysms, intracranial tumors (with the exception of small meningiomas), or intracranial vascular malformations. 4. History of intracranial hemorrhage within 6 months, including parenchymal hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage. 5. History of gastrointestinal hemorrhage, genitourinary bleeding, acute myocardial infarction (AMI), cranial trauma, or having undergone major surgical procedures within the past month. 6. The presence of active bleeding, severe anemia, coagulation dysfunction, or an uncorrected bleeding tendency (platelet count \< 40,000 /μl, uncorrected INR\>2.0). 7. Patients with heart function of grade 1 or above, or with a clear history of acute or chronic heart dysfunction, are at greater risk of acute heart failure or fluid perfusion intolerance as determined by clinicians. 8. Severe heart, liver, kidney disease. 9. Known allergy to contrast media or related medications. 10. Refractory hypertension uncontrolled by medication (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg). 11. glucose \<2.8 mmol/L or \>22.2 mmol/L; 12. Pregnancy or lactation; 13. the expected survival time is less than 12 months. 14. Participating in other clinical trials, in the investigational phase or in the follow-up phase. 15. Other conditions deemed by investigators to pose significant risks or render participation unsuitable (e.g. inability to comply due to psychiatric/cognitive/emotional disorders).

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Conditions

The condition(s) this trial relates to.

Hypothermia stroke disorder

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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