Chilled saline infused directly into brain during stroke treatment may limit damage
NCT ID NCT06485427
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
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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
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258 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Mar 2026
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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967 Hospital of the Joint Logistics Support Force of PLA
Dalian, China
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Affiliated Hospital of Inner Mongolia University for the Nationalities
Tongliao, China
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Beijing Chaoyang Hospital, Capital Medical University
Beijing, China
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Beijing Shijitan Hospital, Capital Medical University
Beijing, China
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Dalian Municipal Central Hospital
Dalian, China
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Department of Neurosurgery, Nanshi Hospital of Nanyang
Nanyang, Henan, China
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Gansu Province Central Hospital
Gansu, China
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Peking University Internation Hospital
Beijing, China
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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
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The First Affiliated Hospital of Harbin Medical University
Ha’erbin, China
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The Second Hospital and Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China
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Zhejiang Provincial People's Hospital
Hangzhou, China
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