Adacolumn blood-cleaning device for brain swelling after a stroke
Tests Adacolumn on brain swelling in adults after a stroke.
Plain-language title generated from the registry record
Registry title: A Trial of Adacolumn on Cerebral Edema After Anterior Circulation Ischemic Stroke
Key facts
- Where
- Hangzhou, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-80 with a severe, acute stroke caused by a blocked large artery at the front of the brain. It tests whether Adacolumn can reduce brain swelling.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke with a proven blockage of the ICA or MCA-M1 artery, shown by MRA, CTA or DSA. NIHSS score of 10 or more at screening. Before the stroke, mRS score below 2 (independent in daily life).
- Earlier treatment
- First Adacolumn treatment must start within 24 hours of stroke onset. Any thrombectomy or thrombolysis must follow the 2024 Chinese Stroke Association guidelines. Decompressive craniectomy before enrollment is not allowed.
- Biomarker or test result
- Blood counts must be in range: neutrophils not below 1.5×10⁹/L and not above 15×10⁹/L, monocytes not above 1.0×10⁹/L, red blood cells not below 3.0×10¹²/L.
Main reasons for not taking part
- Decompressive craniectomy before enrollment or before study treatment starts
- Signs of brain herniation, such as fixed dilated pupils
- Bleeding in the brain after thrombectomy, or active internal bleeding or bleeding tendency
- Fever above 38°C (100.4 °F), active infection, or active autoimmune disease or immunodeficiency
- Cannot have an MRI, or took part in another interventional trial in the past 30 days
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07386262, who can take part
Where in China
- The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07386262
- Record updated
- 7 August 2026
- Original description
The primary objective is to investigate whether treatment with Adacolumn can ameliorate the progression of cerebral edema within 72 hours in patients with anterior circulation ischemic stroke. The secondary objective is to explore if Adacolumn could improve acute neurologic status, functional outcomes, treatment requirements and safety in patients with anterior circulation ischemic stroke.Read full original descriptionShow less
Efficacy and Safety of the Adacolumn® Granulocyte and Monocyte/Macrophage Apheresis Device for Cerebral Edema After Acute Anterior Circulation Occlusive Cerebral Infarction: A Prospective, Randomized, Controlled Clinical Trial
The primary objective is to investigate whether treatment with Adacolumn can ameliorate the progression of cerebral edema within 72 hours in patients with anterior circulation ischemic stroke. The secondary objective is to explore if Adacolumn could improve acute neurologic status, functional outcomes, treatment requirements and safety in patients with anterior circulation ischemic stroke.
Inclusion: Age 18-80 years, regardless of gender; A clinical diagnosis of acute ischemic stroke; 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; NIHSS score ≥10 at screening; Pre-stroke mRS score <2 (independent in all activities of daily living); 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); 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; Written informed consent obtained from the patient or legally authorized representative.
Exclusion: Intracranial or spinal surgery or severe head trauma within the past 3 months; 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); Intracranial lesions conferring markedly increased bleeding risk (known brain tumor, arteriovenous malformation, aneurysm); Refractory hypertension (persistent systolic blood pressure >185 mmHg or diastolic >110 mmHg); Known allergy to components of the blood purification system (including adsorption membrane, anticoagulants); Body temperature >38°C or active infection; Active autoimmune disease or immunodeficiency; Any other condition deemed unsuitable for participation by the investigator; Absolute neutrophil count <1.5×10⁹/L or >15×10⁹/L; Absolute monocyte count > 1.0 ×10⁹/L; Red blood cells <3.0×10¹²/L ; Active internal bleeding or bleeding tendency (such as platelet count <100×10⁹/L, INR >1.7, PT >15 seconds); Marked hypercoagulability (fibrinogen >700 mg/dL); 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); Decompressive craniectomy performed before enrollment or between enrollment and initiation of study treatment; 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; 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; Inability to undergo MRI; Participation in another interventional clinical trial within the past 30 days.