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Combined Selective Endovascular Brain Hypothermia with Edaravone Dexborneol vs Edaravone Dexborneol for Endovascular Treatment of Acute Ischemic Stroke: A Multicenter, Single-blind, Randomized controlled study

Combined Selective Endovascular Brain Hypothermia with Edaravone Dexborneol vs Edaravone Dexborneol for Endovascular Treatment of Acute Ischemic Stroke: A Multicenter, Single-blind, Randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078881
Enrollment
Unknown
Registered
2023-12-20
Start date
2023-12-20
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke

Interventions

intervention group:Selective endovascular brain hypothermia combined with edaravone dexborneol
control group:The control group will receive 300?ml 37? saline (30?ml/min) infused into target vessel through a catheter, and then receive edaravone dexborneol (edaravone dexborneol 15 ml +NS 100 ml i

Sponsors

West China hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1) age between 18 and 80 years; (2) presenting with symptoms consistent with acute ischaemic stroke; (3) anterior circulation LVO confirmed by CTA, MRA or DSA; (3) <6 h from onset of symptom to groin puncture; (5) the baseline NIHSS score before EVT ranged from 6 to 25; (6) pre-mRS=1; (7) informed consent signed

Exclusion criteria

Exclusion criteria: The exclusion criteria include: (1) intracranial hemorrhage before randomization: including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc; (2) severe pneumonia or urinary tract infection; (3) allergic to edaravone dextrocamphenol or excipients; (4) a history of congenital or acquired bleeding disorders, coagulation factor deficiency disorders, and thrombocytopenic disorders; (5) systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg after antihypertensive treatment; (6) serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times higher than the upper limit of normal; (7) recent or current serum creatinine exceeding 1.5 times the upper limit of the normal range or estimated glomerular filtration rate (eGFR) <60 mL/min; (8) patients who are pregnant or breastfeeding and who plan to become pregnant within 90 days; (9) patients with severe mental disorders or dementia who were unable to cooperate with informed consent and follow-up; (10) Patients with concurrent malignancy or severe systemic disease with an expected survival of less than 90 days; (11) has participated in or is currently participating in another clinical intervention study within 30 days before randomization.

Design outcomes

Primary

MeasureTime frame
functional independence;mRS score;SAE;

Secondary

MeasureTime frame
NIHSS score;mortality;Symptomatic intracranial hemorrhage;

Countries

China

Contacts

Public ContactHe Li

West China hospital

heli2003new@126.com+86 189 8060 1670

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026