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Can a blood filter stop brain swelling after stroke?

NCT ID NCT07386262

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This trial tests whether the Adacolumn device, which filters certain white blood cells from the blood, can reduce brain swelling in people who have had a severe stroke. Ten patients will receive the treatment within 24 hours of their stroke. The goal is to see if it prevents worsening of brain edema and improves recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Adacolumn apheresis device
What this could lead to
If it works, this could point toward a new way to reduce dangerous brain swelling after a stroke, potentially improving recovery.
What could go wrong
This is a very early, small trial with only 10 participants, so results may not apply widely. The procedure involves blood filtering, which carries risks like low blood pressure or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-80 years, regardless of gender; 2. A clinical diagnosis of acute ischemic stroke; 3. Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA or DSA; 4. NIHSS score ≥10 at screening; 5. Pre-stroke mRS score \<2 (independent in all activities of daily living); 6. Time from stroke onset to initiation of the first Adacolumn treatment is ≤24 hours, stroke onset is defined as the last time the patient was known to be at their neurological baseline (wake-up strokes qualify if within this time window); 7. All endovascular thrombectomy and/or intravenous thrombolysis must strictly adhere to the "2024 Chinese Stroke Association Guidelines for Reperfusion Therapy in Acute Ischemic Stroke" and the latest prescribing information regarding indications, contraindications, and procedural standards; 8. Written informed consent obtained from the patient or legally authorized representative. Exclusion Criteria: 1. Decompressive craniectomy performed before enrollment or between enrollment and initiation of study treatment; 2. After endovascular thrombectomy: extensive contrast extravasation (diffuse subarachnoid high density or parenchymal high density not consistent with hematoma), new subarachnoid hemorrhage(SAH), or symptomatic intracranial hemorrhage (sICH); 3. Large-vessel occlusion is attributed to other determined etiologies per TOAST classification, such as tumor-related, dissection-related, or other clearly identifiable non-LAA/non-CE causes. 4. Clinical signs of brain herniation, such as unilateral or bilateral fixed dilated pupils and/or other loss of brainstem reflexes attributable to cerebral edema or herniation in the investigator's opinion; 5. Intracranial lesions conferring markedly increased bleeding risk (known brain tumor, arteriovenous malformation, aneurysm); 6. Inability to undergo MRI; 7. Absolute neutrophil count \<1.5×10⁹/L or \>15×10⁹/L 8. Absolute monocyte count \> 1.0 ×10⁹/L; 9. Red blood cells \<3.0×10¹²/L ; 10. Active internal bleeding or bleeding tendency (such as platelet count \<100×10⁹/L, INR \>1.7, PT \>15 seconds); 11. Marked hypercoagulability (fibrinogen \>700 mg/dL); 12. Intracranial or spinal surgery or severe head trauma within the past 3 months; 13. Refractory hypertension (persistent systolic blood pressure \>185 mmHg or diastolic \>110 mmHg); 14. Known allergy to components of the blood purification system (including adsorption membrane, anticoagulants); 15. Acute ST-segment elevation myocardial infarction and/or acute decompensated heart failure and/or corrected QT interval \>520 ms and/or history of cardiac arrest within the past 6 months(pulseless electrical activity, ventricular tachycardia, ventricular fibrillation, or asystole); 16. Body temperature \>38°C or active infection; 17. Active autoimmune disease or immunodeficiency; 18. Participation in another interventional clinical trial within the past 30 days; 19. Any other condition deemed unsuitable for participation by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 311221, China

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