Chilled saline infused directly into brain during stroke treatment may limit damage

NCT ID NCT06485427

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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 Results may not be published yet.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

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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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether infusing cold saline directly into the brain during emergency clot removal can improve recovery after a severe stroke. About 258 adults aged 18 to 80 with a large-vessel blockage in the front part of the brain will be randomly assigned to receive either standard clot removal alone or standard care plus the cooling infusion. The main goal is to see if cooling leads to better functional outcomes three months after the stroke.

What this could mean

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

Active substance
cold saline infusion
What this could lead to
If it works, this cooling method could reduce brain damage and improve recovery after a severe stroke.
What could go wrong
This is a mid-stage trial, so the cooling may not improve outcomes or could cause complications. The approach is still experimental.

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

258 people

The number who actually took part.

Started

Jul 2024

Finished

Mar 2026

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 80 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 1. Age ≥18 and ≤80. 2. Clinical signs consistent with AIS-LVO in the anterior circulation (intracranial segment of internal carotid artery, M1 segment of middle cerebral artery (MCA) demonstrated by computed tomography angiography (CTA) / magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA)). 3. National Institutes of Health Stroke Scale (NIHSS) score (at screening) ≥6 and ≤25. 4. Modified Rankin Scale (mRS) score ≤1 before stroke onset. 5. Arterial puncture performed within 24 hours of symptom onset or last known well (LKW). 6. Written informed consent obtained from the patients or legally authorized representatives. For patients admitted to the hospital within 6 hours of symptom onset, an Alberta Stroke Program Early CT Score (ASPECTS) ≥6 is required. For those admitted between 6 and 24 hours, the neuroimaging criteria of the DAWN or DEFUSE-3 trials are applied. Exclusion Criteria 1. Baseline CT/MRI reveals the presence of acute infarction in multiple vascular territories. 2. CTA/MRA/DSA confirms the presence of arterial dissection. 3. Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy. 4. Known allergies or intolerances to antiplatelet agents, anticoagulants, iodinated contrast, or anesthetics. 5. Severe infection (e.g., sepsis) or multiple organ failure. 6. Known hereditary or acquired hemorrhagic diathesis; coagulation factor deficiency; recent oral anticoagulant therapy with international normalized ratio (INR)\>3. Exception: Time elapsed since the last use of a novel oral anticoagulant ≥48 hours plus a normal activated partial thromboplastin time (APTT). 7. Baseline platelet count \<50 × 109/L. 8. Blood glucose concentration \<50 mg/dL (2.7 mmol/L) or \>400 mg/dL (22.2 mmol/L). 9. Refractory hypertension that is difficult to control by medication (persistent systolic blood pressure (BP) \>185 mmHg or diastolic BP \>110 mmHg). 10. Previous New York Heart Association (NYHA) functional classification \>I. 11. Coronary artery stenosis \>70% or history of coronary artery bypass grafting. 12. Undergoing hemodialysis or peritoneal dialysis; severe renal insufficiency with a glomerular filtration rate \<30 mL/min or serum creatinine \>220 mmol/L (2.5 mg/dL). 13. Known intracranial aneurysm or cerebral arteriovenous malformation. 14. Malignant brain tumor or central nervous system infection. 15. Pre-existing neurological or psychiatric diseases that could confound the neurological or functional evaluations (e.g., dementia or mental illness) 16. Pregnant or lactating at admission. 17. Anticipated life expectancy \<6 months. 18. Current participation in another interventional drug or device study. For any other reasons, the responsible clinicians believe that the patient is not suitable for SI-AC.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • 967 Hospital of the Joint Logistics Support Force of PLA

    Dalian, China

  • Affiliated Hospital of Inner Mongolia University for the Nationalities

    Tongliao, China

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, China

  • Beijing Shijitan Hospital, Capital Medical University

    Beijing, China

  • Dalian Municipal Central Hospital

    Dalian, China

  • Department of Neurosurgery, Nanshi Hospital of Nanyang

    Nanyang, Henan, China

  • Gansu Province Central Hospital

    Gansu, China

  • Peking University Internation Hospital

    Beijing, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, China

  • The First Affiliated Hospital of Harbin Medical University

    Ha’erbin, China

  • The Second Hospital and Clinical Medical School, Lanzhou University

    Lanzhou, Gansu, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, China

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