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RecruitingNCT07127484Updated Sep 4, 2026

Hemoadsorption for Severe Ischemic Stroke

An interventional study of Hemoadsorption in Ischemic Stroke and Hemoadsorption, sponsored by First Affiliated Hospital of Wannan Medical College. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by First Affiliated Hospital of Wannan Medical College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Ischemic Stroke
  • Hemoadsorption

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03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 116 is close to the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

First Affiliated Hospital of Wannan Medical College is the lead sponsor of 36 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
116 participants (estimated)

Study arms

  • No intervention
    standard treatment group
  • Other
    standard treatment plus hemoadsorption group

    Procedure: Hemoadsorption

Interventions

  • ProcedureHemoadsorption

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

06

What researchers measure

Primary outcomes

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

    Time frame: From enrollment to the end of treatment at 90 days

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)
    Wuhu, Anhui, China
    • Fanfu Jin, Master · Contact · 18356201996@sina.cn · +86 18356201996
    • Shoucai Zhao, Doctor · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07127484
Lead sponsor
First Affiliated Hospital of Wannan Medical College
Collaborators
Anqing Municipal Hospital, Beijing Tiantan Hospital, Baotou Central Hospital, The NO.1 People's Hospital of Shizuishan, Fuyang people's hospital, Second People's Hospital of Hefei City, The First Affiliated Hospital of Zhengzhou University, THE SECOND PEOPLE'S HOSPITAL, WUHU
Responsible party
Jie Xu (Director, First Affiliated Hospital of Wannan Medical College) — Principal investigator
First posted
Aug 17, 2025
Start date
Jan 5, 2026
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Fanfu Jin, Master
Contact
18356201996@sina.cn
+86 18356201996

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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