Assessing a new cooling technique for stroke treatment

Local Hypothermia and Endovascular Recanalization for Acute Large Artery Occlusive Stroke-A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial

This study is testing a new cooling method during stroke treatment to see if it helps patients recover better than the usual care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 262 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Guangdong Second Provincial General Hospital (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06758609 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness and safety of a novel approach combining catheter-based focal intracranial hypothermia with endovascular reperfusion therapy for patients suffering from acute anterior circulation large artery occlusion. Participants will be randomly assigned to receive either mechanical thrombectomy with hypothermia or standard treatment with normothermia. The study employs a stratified randomization method based on specific clinical criteria to ensure balanced groups. The goal is to determine if this innovative cooling technique can improve outcomes for stroke patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who exhibit sudden neurological impairment due to anterior circulation large artery occlusion.

Not a fit: Patients with conditions that prevent safe participation in the procedures or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance recovery and reduce damage in stroke patients.

How similar studies have performed: While similar approaches have been explored, this specific combination of techniques is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 and ≤85 years old.
2. Symptoms of sudden focal or general neurological impairment.
3. There may be a causal relationship between vascular occlusion and nerve function defect.
4. Time from symptom onset to randomization ≤24h.
5. The National Institutes of Health Stroke Scale (NIHSS) score was ≥6 points before randomization.
6. According to the judgment of the clinician, the operation path is reasonable, and the operation and operation related instruments can reach the disease smoothly.
7. 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.
8. Prior to randomization, CTA, MRA, or DSA confirmed the presence of anterior circulatory large vessel occlusion (internal carotid artery or M1segment).
9. The symptoms are aggravated by recurrent cerebral infarction in the same drainage basin and/or the pathogenesis is caused by decreased blood perfusion.

Exclusion Criteria:

1. Pre stroke mRS\>1 score.
2. There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
3. NIHSS≤6 points.
4. Cerebral hemorrhage/subarachnoid hemorrhage was confirmed by CT or MRI. 5.The presence of active bleeding, severe anemia, coagulation dysfunction, or an uncorrected bleeding tendency (Presence of at least one of the following laboratory tests: hemoglobin \< 10g /dl, platelet count \< 100,000 /μl, uncorrected INR\>1.5, PT\> 1 minute above the upper limit of normal, or heparin-related thrombocytopenia).

6.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.

7\. Severe heart, liver, kidney disease. 8.With malignant diseases such as malignant tumors, the expected survival time is less than 3 months.

9.Participating in other clinical trials, in the investigational phase or in the follow-up phase.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Second Provincial General Hospital — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Zhixin Huang, PhD

Conditions: Acute Cerebrovascular Accident, Acute Ischemic Stroke, Internal Carotid Artery, Middle Cerebral Artery Occlusion