Hemoadsorption for Severe Ischemic Stroke

Efficacy and Safety of Hemoadsorption for Severe Ischemic Stroke

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

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Hemoadsorption
• Intervention / Treatment: Procedure: Hemoadsorption

Detailed Description

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. During the study period, a total of 116 patients with severe ischemic stroke will be enrolled from 10 centers. To evaluate whether adjunctive hemoadsorption therapy combined with standard treatment can reduce the incidence of severe adverse functional outcomes (modified Rankin Scale [mRS] 4-6) at 90 days. Patients in control group will receive standard treatment, and those in the other group will receive standard treatment plus hemoadsorption therapy administered once on days 1, 3, and 5 following enrollment. Study visits will be performed on the day of randomization, at treatment period, at day 7, at day 14 or hospital discharge and at day 90. In addition to the primary endpoint, the study will evaluate whether hemoadsorption can reduce acute-phase inflammatory cytokine levels and decrease the incidence of complications including hemorrhagic transformation, malignant cerebral edema, and pulmonary infections in severe ischemic stroke patients.

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fanfu Jin, Master; Phone Number: +86 18356201996; Email: 18356201996@sina.cn

Study Locations

• China
  • Anhui
    • Wuhu, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)
      • Contact: Fanfu Jin, Master; Phone Number: +86 18356201996; Email: 18356201996@sina.cn
      • Principal Investigator: Shoucai Zhao, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard treatment group
Other: standard treatment plus hemoadsorption group	Procedure: Hemoadsorption; Patients in intervention group will receive standard treatment plus hemoadsorption therapy administered once on days 1, 3, and 5 following enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of severe adverse functional outcomes (modified Rankin Scale [mRS] 4-6)	From enrollment to the end of treatment at 90 days

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wannan Medical College
• Collaborators: Beijing Tiantan Hospital; The First Affiliated Hospital of Zhengzhou University; Anqing Municipal Hospital; Baotou Central Hospital; Fuyang people's hospital; Gansu Provincial Central Hospital; Second People's Hospital of Hefei City; THE SECOND PEOPLE'S HOSPITAL, WUHU; The NO.1 People's Hospital of Shizuishan

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: August 11, 2025
• First Submitted That Met QC Criteria: August 11, 2025
• First Posted (Actual): August 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 202510

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No