Hemoadsorption for Severe Ischemic Stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial evaluates the safety and efficacy of adjunctive hemoadsorption in adults with severe ischemic stroke. Participants are assigned to standard treatment plus hemoadsorption on days 1, 3, and 5, or to standard treatment alone, with follow-up through day 90. The primary outcome is favorable functional status at 90 days, measured by modified Rankin Scale scores of 0–3 versus 4–6. Secondary objectives include changes in acute inflammatory markers and the incidence of complications such as hemorrhagic transformation, malignant edema, and pulmonary infections. The trial plans to enroll 116 patients across about 10 centers, with structured visits around randomization, treatment periods, and follow-up assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1.18 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:

1. 15≤ NIHSS score ≤32;
2. 3\<GCS score ≤12;
3. 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 Criteria:

1. Hemorrhagic transformation of PH2 type prior to randomization;
2. Brain herniation or decompressive craniectomy performed before randomization;
3. 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);
4. 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);
5. Coagulopathy or thrombocytopenia (platelet count \<100×10⁹/L);
6. Deep vein thrombosis (DVT) of the lower extremities before randomization;
7. Life expectancy \<90 days due to malignancy;
8. Participation in another drug or device clinical trial within the past 30 days or ongoing enrollment in such trials;
9. Women of childbearing potential with a negative pregnancy test who refuse to use effective contraception, or pregnant/lactating women;
10. Absolute contraindications to hemoadsorption therapy.

Where it's running

• The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)
  Wuhu, Anhui, China Recruiting

Study contacts

• Study coordinator: Fanfu Jin, Master
• Email: 18356201996@sina.cn
• Phone: +86 18356201996

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.