Can a blood filter stop brain swelling after stroke?
NCT ID NCT07386262
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute ischemic stroke due to anterior circulation large-artery occlusion are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- AI as a second opinion for stroke: a smarter path to Clot-Busting?
- Can an earthworm enzyme boost stroke recovery?
- Can a Rapid-Acting clot blocker boost stroke recovery?
- Could adding Clot-Busting drugs before surgery boost stroke recovery?
- Can a common antibiotic shield the brain after a stroke?
- Can a simple relaxation technique soothe the mind after a stroke?