Hemoadsorption for Severe Ischemic Stroke

Официальное название

Efficacy and Safety of Hemoadsorption for Severe Ischemic Stroke

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура Hemoadsorption
  Patients in intervention group will receive standard treatment plus hemoadsorption therapy administered once on days 1, 3, and 5 following enrollment.

Первичные конечные точки

• The incidence of severe adverse functional outcomes (modified Rankin Scale [mRS] 4-6) [Срок оценки: From enrollment to the end of treatment at 90 days]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital) — Wuhu

Идентификаторы

NCT: NCT07127484 · 202510

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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