TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage

Официальное название

TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage (TIME-ICH): A Prospective, Multi-center, Open-label, Adaptive, Randomized Controlled Trial

Обзор

TIME-ICH (TrIal of early Minimally Invasive catheter Evacuation with thrombolysis in IntraCerebral Hemorrhage) is a multicenter, randomized, adaptive clinical trial comparing best medical management to early minimally invasive surgery with thrombolysis (eMIST) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.

Подробное описание

Patients presenting to the emergency department with stroke due to supratentorial, spontaneous intracerebral hemorrhage ≥20mL volume will be assessed to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomized 1:1 using central computerized allocation to early minimally invasive surgery with thrombolysis versus best medical management. The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design. Adaptive sample size re-estimation will be performed when 250 patients have completed 180 days follow-up. Clinical efficacy will be determined by demonstrating an improvement in functional outcome, as determined by a blinded-assessment of the 180-day utility-weighted modified Rankin Scale (mRS).

Вмешательства

• Процедура Early Minimally Invasive Surgery with Thrombolysis (eMIST)
  Subjects will undergo minimally invasive catheter evacuation in the early stage of intracranial hemorrhage. Up to 10 doses of 50000U of urokinase will be administered through the catheter that was placed directly into the intracerebral hemorrhage.

Первичные конечные точки

• Functional Improvement - uw-mRS [Срок оценки: 180 days]

Вторичные конечные точки (6)

• Functional Improvement - uw-mRS [Срок оценки: 7 days, 14 days (discharge), 30 days and 90 days]
• Functional Improvement - good functional outcome [Срок оценки: 7 days, 14 days (discharge), 30 days, 90 days and 180 days]
• Mortality [Срок оценки: 180 days]
• Clot Removal - Amount of Residual Blood [Срок оценки: 36 hours, 7 days and 14 days (discharge)]
• Health-related quality of life - EQ-5D-5L [Срок оценки: 14 days (discharge), 30 days, 90 days and 180 days]
• Activities of Daily Living - Barthel Index [Срок оценки: 14 days (discharge), 30 days, 90 days and 180 days]

Критерии участия

Критерии включения

• Age ≥ 18 years;
• Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH;
• ICH volume ≥ 20mL as calculated by the ABC/2 method;
• The randomization can be completed within 8 hours after the onset of stroke symptoms (or the time last known to be well), and study intervention can reasonably be initiated within 4 hours after randomization.
• Historical Modified Rankin Score 0 or 1;
• Obtain informed consent from patient or legal representative.

Критерии исключения

• Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar;
• Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, tumor stroke, recurrence of a recent (<1 year) ICH, as diagnosed with radiographic imaging;
• Presence of spot sign in CT angiography;
• Blood pressure control before randomization is ineffective, systolic blood pressure > 220 mmHg;
• Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4;
• Hemorrhage with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions;
• Intraventricular extension of the Hemorrhage is visually estimated to involve >50% of either of the lateral ventricles;
• Any irreversible coagulopathy or known clotting disorder.
• Platelet count < 750,000, INR > 1.4 after correction
• Patients requiring long-term anti-coagulation that needs to be initiated < 30 days from index ICH;
• Use of 2 or more antithrombotic drugs prior to symptom onset;
• Patients with a mechanical heart valve;
• Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or is post-menopausal;
• Urokinase allergy;
• Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
• Inability or unwillingness of patient or legal representative to give written informed consent;
• Known life-expectancy of less than 6 months;
• Participation in a concurrent interventional medical investigation or clinical trial.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 50 центров

• Guangdong Provincial People's Hospital — Guangdong
• Guangde People's Hospital — Anhui
• Beijing Chao-Yang Hospital, Capital Medical University — Пекин
• Beijing Daxing District People's Hospital — Пекин
• Beijing Fengtai You'anmen Hospital — Пекин
• Beijing Friendship Hospital, Capital Medical University — Пекин
• Peking University Aerospace Central Hospital — Пекин
• Shunyi District Hospital in Beijing — Пекин
• … и ещё 42 центра

Идентификаторы

NCT: NCT07187687 · TIME-ICH-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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