Ischemic StrokeNCT07127484
Hemoadsorption for Severe Ischemic Stroke
A study testing Hemoadsorption in people with Ischemic Stroke and Hemoadsorption, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Hemoadsorption
- What is being tested?
- Hemoadsorption
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 15≤ NIHSS score ≤32;
- 3<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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)
Wuhu, Anhui
Fanfu Jin, Master, +86 18356201996, 18356201996@sina.cn
Shoucai Zhao, Doctor
About this study
Official title: 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
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.
- Conditions
- Ischemic Stroke, Hemoadsorption
- Being tested
- Hemoadsorption
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoadsorptionProcedure or surgery
Patients in intervention group will receive standard treatment plus hemoadsorption therapy administered once on days 1, 3, and 5 following enrollment.
| Study group | Role | What they receive |
|---|---|---|
| standard treatment group | No intervention | Not described |
| standard treatment plus hemoadsorption group | Other | Not described Receives: Procedure: Hemoadsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of severe adverse functional outcomes (modified Rankin Scale [mRS] 4-6)
Measured: From enrollment to the end of treatment at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start5 Jan 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- 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, Wuhu City Second People's Hospital
- Responsible party
- Principal investigator, Jie Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127484
- Sponsor's protocol ID
- 202510
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hemoadsorption for Severe Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07127484
- Acronym / sponsor ID
- 202510
- Conditions
- Ischemic Stroke, Hemoadsorption
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- 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, Wuhu City Second People's Hospital
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard treatment group | No intervention | – |
| standard treatment plus hemoadsorption group | Other | Procedure: Hemoadsorption |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
- 15≤ NIHSS score ≤32;
- 3<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.
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemoadsorptionPatients in intervention group will receive standard treatment plus hemoadsorption therapy administered once on days 1, 3, and 5 following enrollment. | Procedure or surgery | standard treatment plus hemoadsorption group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemoadsorption in people with Ischemic Stroke and Hemoadsorption, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fanfu Jin, Master (+86 18356201996, 18356201996@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.