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临床试验/EUCTR2013-002818-12-GB
EUCTR2013-002818-12-GB进行中（未招募）1 期

A phase III, randomized, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral haemorrhage. - Minimally invasive surgery for ICH (MISTIE III)

The John Hopkins University0 个研究点目标入组 499 人开始时间: 2014年5月15日最近更新:
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适应症
相关药物

试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
499
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • •1) Spontaneous supratentorial ICH = 30 mL measured by the site utilizing ABC/2 method using radiographic imaging (CT, CTA, etc.), with a GCS = 14 or a NIHSS = 6.
  • •2) Stability CT scan done at least 6 hours after diagnostic CT showing clot stability (growth < 5 mL as measured by ABC/2 method).
  • •If the clot volume measured on this stability CT scan increases by 5 mL or more, a second stability determination is allowed by repeat CT scan at least 12 hours later. Additional scans are permitted as needed every 12 hours to continue to monitor for stability up until the eligibility time window closes. Subsequent clot retraction remains inclusionary as long as the ICH clot size remains = 25 mL.
  • •3) Symptoms less than 24 hours prior to diagnostic CT (dCT) scan. An unknown time of onset is exclusionary. Use the time the patient was last known to be well for patients that awaken from sleep with symptoms.
  • •4) Ability to randomize between 12 and 72 hours after dCT.
  • •5) SBP < 180 mmHg sustained for six hours recorded closest to the time of randomization.
  • •6) Historical Rankin score of 0 or 1.
  • •7) Age = 18 and older.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 250
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 250

排除标准

  • •1) Infratentorial hemorrhage.
  • •2) Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (< 1 year) hemorrhage, diagnosed with radiographic imaging.
  • •3) Patients with unstable mass or evolving intracranial compartment syndrome.
  • •4) Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS = 4.
  • •5) Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions. Note: Patients with a posterior fossa ICH or cerebellar hematomas are ineligible.
  • •6) Intraventricular hemorrhage requiring treatment for IVH-related (casting) mass effect or shift due to trapped ventricle. EVD to treat ICP is allowed.
  • •7) Platelet count < 100,000; INR > 1.4.
  • •8) Any irreversible coagulopathy or known clotting disorder.
  • •9) Inability to sustain INR = 1.4 using short- and long-acting procoagulants (such as but not limited to NovoSeven, FFP, and/or vitamin K).
  • •10) Subjects requiring long-term anti-coagulation are excluded. Reversal of anticoagulation is permitted for medically stable patients who can realistically tolerate the short term risk of reversal. Patient must not require Coumadin (anticoagulation) during the first 30 days, and normalized coagulation parameters must be demonstrated, monitored closely and maintained during the period of brain instrumentation.
  • •11) Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.
  • •12) Internal bleeding involving retroperitoneal, gastrointestinal, or genitourinary site or respiratory tract bleeding.
  • •13) Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures, etc.) or site of recent surgical intervention.
  • •14) Positive urine or serum pregnancy test in pre-menopausal female subjects without a documented history of surgical sterilization.
  • •15) Allergy/sensitivity to rt-PA.
  • •16) Prior enrollment in the study.
  • •17) Participation in a concurrent interventional medical investigation or clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving an intervention are eligible.
  • •18) Not expected to survive to the day 365 visit due to co-morbidities, or are DNR/DNI status prior to randomization.
  • •19) Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
  • •20) Patients with a mechanical heart valve. Presence of bio-prosthetic valve(s) is permitted.
  • •21) Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is permitted.
  • •22) Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy

研究者

发起方
The John Hopkins University

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