RecruitingNot ApplicableNCT07127484

Hemoadsorption for Severe Ischemic Stroke

Efficacy and Safety of Hemoadsorption for Severe Ischemic Stroke

Sponsor

First Affiliated Hospital of Wannan Medical College

Enrollment

116 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Ischemic Stroke Hemoadsorption

Summary

This is a multicenter, randomized-controlled, open-label, blinded endpoint clinical trial that aims to evaluate the efficacy and safety of hemoadsorption for severe ischemic stroke

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

18 years ≤ age < 80 years; 2.Pre-stroke mRS score ≤ 1; 3.Anterior circulation cerebral infarction within 48 hours of onset, meeting at least one of the following:
15≤ NIHSS score ≤32;
3<GCS score ≤12;
CT hypodensity area >1/2 of the MCA territory; 4.hs-CRP ≥2 mg/L at randomization; 5.If reperfusion therapy is performed, no improvement in NIHSS score (still ≤32) post-treatment; 6.Signed informed consent obtained.

Exclusion Criteria10

Hemorrhagic transformation of PH2 type prior to randomization;
Brain herniation or decompressive craniectomy performed before randomization;
Hemodynamic instability refractory to medical correction (systolic blood pressure <70 mmHg or diastolic blood pressure <50 mmHg) or decompensated heart failure (NYHA Class III or IV);
Severe hepatic impairment (defined as ALT >2 times the upper limit of normal or AST >2 times the upper limit of normal) and renal impairment (defined as serum creatinine >1.5 times the upper limit of normal or estimated glomerular filtration rate \[eGFR\] <50 mL/min);
Coagulopathy or thrombocytopenia (platelet count <100×10⁹/L);
Deep vein thrombosis (DVT) of the lower extremities before randomization;
Life expectancy <90 days due to malignancy;
Participation in another drug or device clinical trial within the past 30 days or ongoing enrollment in such trials;
Women of childbearing potential with a negative pregnancy test who refuse to use effective contraception, or pregnant/lactating women;
Absolute contraindications to hemoadsorption therapy.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREHemoadsorption

Patients in intervention group will receive standard treatment plus hemoadsorption therapy administered once on days 1, 3, and 5 following enrollment.