Hemoadsorption for Severe Ischemic Stroke

NCT07127484 | Not Yet Recruiting

• 1 other identifier: 202510
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Ischemic Stroke; Hemoadsorption

Outcome Measures

Primary Outcomes (1)

• The incidence of severe adverse functional outcomes (modified Rankin Scale [mRS] 4-6)

  From enrollment to the end of treatment at 90 days

Study Arms (2)

standard treatment group

NO INTERVENTION

standard treatment plus hemoadsorption group

OTHER

Procedure: Hemoadsorption

Interventions

Hemoadsorption PROCEDURE

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

standard treatment plus hemoadsorption group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ≤ NIHSS score ≤32;
• \<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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead
• The Second People's Hospital of Wuhu: collaborator
• Anqing People's Hospital of Anhui Medical University: collaborator
• Beijing Tiantan Hospital: collaborator
• Gansu Provincial Central Hospital: collaborator
• Baotou Central Hospital: collaborator
• The NO.1 People's Hospital of Shizuishan: collaborator
• Fuyang people's hospital: collaborator
• Second People's Hospital of Hefei City: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Luan people's hospital: collaborator

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-08