NCT07127484

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jan 2026Feb 2027

First Submitted

Initial submission to the registry

August 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

May 15, 2026

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

August 11, 2025

Last Update Submit

May 13, 2026

Conditions

Ischemic StrokeHemoadsorption

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

HemoadsorptionPROCEDURE

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

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)

Wuhu, Anhui, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Fanfu Jin, Master

CONTACT

+86 1835620199618356201996@sina.cn

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

January 5, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

May 15, 2026

Record last verified: 2025-08

Locations

CN(1)