A Trial of Adacolumn on Cerebral Edema After Anterior Circulation Ischemic Stroke

NCT07386262 | Not Yet Recruiting

• 1 other identifier: 2025-1867
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Edema; Ischemic Stroke, Acute; Malignant Cerebral Edema; Anterior Circulation Brain Infarction

Outcome Measures

Primary Outcomes (1)

• The change in net water uptake (NWU) on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion

  The change in net water uptake (NWU) measured on CT at 72-78 hours post-reperfusion, compared to the immediate post-reperfusion CT

  72 hours

Secondary Outcomes (12)

• Serious adverse events (SAEs) related to Adacolumn treatment (Primary Safety Outcome)

  Randomization to Day 90

• The number of discontinuation of Adacolumn therapy due to adverse events (Safety Outcome)

  Randomization up to Day 3

• The change in midline shift on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion

  72 hours

• Change in National Institutes of Health Stroke Scale (NIHSS) score on day 7 post-treatment compared to immediate post-operative baseline

  Day 7

• Number of participants who developed brain herniation after treatment

  Baseline up to Day 14

Other Outcomes (2)

• Dynamic changes in peripheral blood immune cells before and after Adacolumn therapy

  Baseline up to Day 3、 Day 7

• Cerebral immune cell infiltration analysis

  Baseline up to Day 14

Study Arms (2)

Device: Adacolumn®

EXPERIMENTAL

Adacolumn Treatment Combined with Endovascular Thrombectomy and Standard Medical Therapy

Device: Adacolumn®; Procedure: Endovascular Thrombectomy; Drug: Standard medical management

Standard Treatment

ACTIVE COMPARATOR

Endovascular Thrombectomy and Standard Medical Therapy

Procedure: Endovascular Thrombectomy; Drug: Standard medical management

Interventions

Standard medical management DRUG

Standard medical management for ischemic stroke.

Device: Adacolumn®; Standard Treatment

Adacolumn® DEVICE

Adacolumn treatment ：once a day for 4 consecutive days after enrollment (60 minutes each time, blood flow rate 30 mL/min, total blood volume processed 1800 mL); the treatment was performed by establishing extracorporeal circulation through bilateral arm veins, and a total of 4 adsorption treatments were completed.

Device: Adacolumn®

Endovascular Thrombectomy PROCEDURE

Endovascular thrombectomy will be performed in strict accordance with the indications, contraindications, and operational specifications outlined in the Chinese Stroke Society Guidelines for Reperfusion Therapy in Acute Ischemic Stroke (2024), as well as the latest official instructions for use of the relevant endovascular devices and adjunctive medications.

Device: Adacolumn®; Standard Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 procedures must strictly adhere to the "2024 Chinese Stroke Association Guidelines for Reperfusion Therapy in Acute Ischemic Stroke" and the latest prescribing information/instructions for use regarding indications, contraindications, and procedural standards;
• Written informed consent obtained from the patient or legally authorized representative.

You may not qualify if:

• Decompressive craniectomy performed before enrollment or between enrollment and initiation of study treatment;
• Patients who receive intravenous thrombolysis (including bridging therapy) for the index ischemic stroke episode before or during endovascular thrombectomy; or undergo permanent intracranial or extracranial stent implantation (including intracranial stent-assisted thrombectomy or carotid stenting) during the index endovascular procedure;
• 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);
• 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;
• Intracranial lesions conferring markedly increased bleeding risk (known brain tumor, arteriovenous malformation, aneurysm);
• Inability to undergo MRI;
• 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);
• Intracranial or spinal surgery or severe head trauma within the past 3 months;
• 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);

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 311221, China

Location

Related Publications (8)

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  PMID: 26818659 BACKGROUND

• Elkins J, Veltkamp R, Montaner J, Johnston SC, Singhal AB, Becker K, Lansberg MG, Tang W, Chang I, Muralidharan K, Gheuens S, Mehta L, Elkind MSV. Safety and efficacy of natalizumab in patients with acute ischaemic stroke (ACTION): a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Neurol. 2017 Mar;16(3):217-226. doi: 10.1016/S1474-4422(16)30357-X. Epub 2017 Feb 15.

  PMID: 28229893 BACKGROUND

• Ren T, Zhu M, Jiang X, Xu L, Jin H, Zhou Y, Zhao Y, Zhuo R, Li W, Chen C, Peng L, Jin X, Li Y, Yang L. Targeting microglial PPARalpha ameliorates the outcome of ischemic stroke by enhancing interaction with infiltrating peripheral monocytes/macrophages. Cell Rep. 2025 Jul 22;44(7):115875. doi: 10.1016/j.celrep.2025.115875. Epub 2025 Jun 20.

  PMID: 40543039 BACKGROUND

• Shi K, Tian DC, Li ZG, Ducruet AF, Lawton MT, Shi FD. Global brain inflammation in stroke. Lancet Neurol. 2019 Nov;18(11):1058-1066. doi: 10.1016/S1474-4422(19)30078-X. Epub 2019 Jul 8.

  PMID: 31296369 BACKGROUND

• Huttner HB, Schwab S. Malignant middle cerebral artery infarction: clinical characteristics, treatment strategies, and future perspectives. Lancet Neurol. 2009 Oct;8(10):949-58. doi: 10.1016/S1474-4422(09)70224-8.

  PMID: 19747656 BACKGROUND

• Wu S, Yuan R, Wang Y, Wei C, Zhang S, Yang X, Wu B, Liu M. Early Prediction of Malignant Brain Edema After Ischemic Stroke. Stroke. 2018 Dec;49(12):2918-2927. doi: 10.1161/STROKEAHA.118.022001.

  PMID: 30571414 BACKGROUND

• Sheth KN, Petersen NH, Cheung K, Elm JJ, Hinson HE, Molyneaux BJ, Beslow LA, Sze GK, Simard JM, Kimberly WT. Long-Term Outcomes in Patients Aged </=70 Years With Intravenous Glyburide From the Phase II GAMES-RP Study of Large Hemispheric Infarction: An Exploratory Analysis. Stroke. 2018 Jun;49(6):1457-1463. doi: 10.1161/STROKEAHA.117.020365. Epub 2018 May 22.

  PMID: 29789393 BACKGROUND

• Huang X, Yang Q, Shi X, Xu X, Ge L, Ding X, Zhou Z. Predictors of malignant brain edema after mechanical thrombectomy for acute ischemic stroke. J Neurointerv Surg. 2019 Oct;11(10):994-998. doi: 10.1136/neurintsurg-2018-014650. Epub 2019 Feb 23.

  PMID: 30798266 BACKGROUND

MeSH Terms

Conditions

Brain Edema; Ischemic Stroke; Brain Infarction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Jianmin Zhang

CONTACT

+86 13805722695; zjm135@zju.edu.cn

Ligen Shi

CONTACT

+86 13732233245; slg0904@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 5, 2026

Record last verified: 2025-12

Locations

CN (1)