Hemoadsorption for Severe Ischemic Stroke

NCT ID: NCT07127484

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2026-12-30

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

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.

Conditions

Ischemic Stroke; Hemoadsorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard treatment plus hemoadsorption group

Group Type: OTHER

Hemoadsorption

Intervention Type: PROCEDURE

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

standard treatment group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hemoadsorption

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second People's Hospital of Wuhu

UNKNOWN

Sponsor Role: collaborator

Anqing People's Hospital of Anhui Medical University

UNKNOWN

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

Gansu Provincial Central Hospital

UNKNOWN

Sponsor Role: collaborator

Baotou Central Hospital

OTHER

Sponsor Role: collaborator

The NO.1 People's Hospital of Shizuishan

UNKNOWN

Sponsor Role: collaborator

Fuyang people's hospital

OTHER

Sponsor Role: collaborator

Second People's Hospital of Hefei City

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Luan people's hospital

UNKNOWN

Sponsor Role: collaborator

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Jie Xu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

202510

Identifier Type: -

Identifier Source: org_study_id