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임상시험 NCT07187687 (TIME-ICH)은(는) 뇌내 출혈에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage (TIME-ICH) 750 무작위 배정 적응형 설계

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임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07187687 (TIME-ICH)은(는) 뇌내 출혈에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 10월 24일에 시작되어 750명의 참여자를 모집하고 있습니다. Xuanwu Hospital, Beijing이(가) 진행하며, 2028년 3월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 9일에 갱신되었습니다.
간단한 개요
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.
상세한 설명
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 pr...더 보기
공식 제목

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

질환명
뇌내 출혈
기타 연구 식별자
  • TIME-ICH
  • TIME-ICH-2025
NCT 번호
NCT07187687
실제 연구 시작일
2025-10-24
최신 업데이트 게시
2026-03-09
예상 연구 완료일
2028-03-01
계획된 등록 인원
750
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
Intracerebral Hemorrhage
Intracranial Hemorrhages
ICH
brain hemorrhage
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Minimally invasive catheter evacuation
Minimally invasive surgery
Neurosurgery
Thrombolysis
Urokinase
Medical Economic
Hospital Economics
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Early Minimally Invasive Surgery with Thrombolysis (eMIST) plus best medical management (BMM)
Subjects will undergo minimally invasive catheter evacuation followed by up to 10 doses of 50000U of urokinase for intracerebral hemorrhage clot resolution.
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.
비개입Best medical management (BMM)
Subjects will receive standard of care medical management for ICH.
해당 없음
주요결과변수
결과변수측정값 설명시간 범위
Functional Improvement - uw-mRS
Functional Improvement as determined by utility-weighted modified Rankin Scale (uw-mRS) which is assigned to seven levels: 1.0, 0.91, 0.76, 0.65, 0.33, 0.0, and 0.0 (with higher scores indicating a better outcome, according to patients' assessment) at 180-days.
180 days
이차결과변수
결과변수측정값 설명시간 범위
Functional Improvement - uw-mRS
Functional Improvement as determined by utility-weighted modified Rankin Scale (uw-mRS) which is assigned to seven levels: 1.0, 0.91, 0.76, 0.65, 0.33, 0.0, and 0.0 (with higher scores indicating a better outcome, according to patients' assessment) at 7 days, 14 days/discharge, 30 days and 90 days.
7 days, 14 days (discharge), 30 days and 90 days
Functional Improvement - good functional outcome
Good functional outcome as determined by modified Rankin Scale (mRS) 0-3 at 7 days, 14 days/discharge, 30 days, 90 days and 180 days
7 days, 14 days (discharge), 30 days, 90 days and 180 days
Mortality
Mortality at 180 days.
180 days
Clot Removal - Amount of Residual Blood
Clot Removal will be assessed by the amount of residual blood at 36 hours, 7 days and 14 days/discharge.
36 hours, 7 days and 14 days (discharge)
Health-related quality of life - EQ-5D-5L
Health-related quality of life will be assessed by EuroQol five-dimension, five-level (EQ-5D-5L) which consists of two parts, a short descriptive system questionnaire and a visual analogue scale (EQ VAS) at 7 days, 14 days/discharge, 30 days, 90 days and 180 days.
14 days (discharge), 30 days, 90 days and 180 days
Activities of Daily Living - Barthel Index
Activities of Daily Living will be assessed by Barthel Index at 14 days/discharge, 30 days, 90 days and 180 days.
14 days (discharge), 30 days, 90 days and 180 days
참여 도우미
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
  1. Age ≥ 18 years;
  2. Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH;
  3. ICH volume ≥ 20mL as calculated by the ABC/2 method;
  4. 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.
  5. Historical Modified Rankin Score 0 or 1;
  6. Obtain informed consent from patient or legal representative.

  1. Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar;
  2. 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;
  3. Presence of spot sign in CT angiography;
  4. Blood pressure control before randomization is ineffective, systolic blood pressure > 220 mmHg;
  5. Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4;
  6. Hemorrhage with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions;
  7. Intraventricular extension of the Hemorrhage is visually estimated to involve >50% of either of the lateral ventricles;
  8. Any irreversible coagulopathy or known clotting disorder.
  9. Platelet count < 750,000, INR > 1.4 after correction
  10. Patients requiring long-term anti-coagulation that needs to be initiated < 30 days from index ICH;
  11. Use of 2 or more antithrombotic drugs prior to symptom onset;
  12. Patients with a mechanical heart valve;
  13. Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or is post-menopausal;
  14. Urokinase allergy;
  15. Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
  16. Inability or unwillingness of patient or legal representative to give written informed consent;
  17. Known life-expectancy of less than 6 months;
  18. Participation in a concurrent interventional medical investigation or clinical trial.
Xuanwu Hospital, Beijing logoXuanwu Hospital, Beijing
연구 대표 연락처
연락처: Tao Hong, MD, PhD, +86 10 8319 8948, [email protected]
연락처: Shaohua Mo, MD, +86 10 8319 8948
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