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临床试验/ISRCTN81927110
ISRCTN81927110已完成3 期

A phase III, randomized, open-label, 500-subject clinical trial of minimally invasive surgery plus rtPA in the treatment of intracerebral haemorrhage

Johns Hopkins University0 个研究点目标入组 500 人开始时间: 2014年8月8日最近更新:
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试验速览

阶段
3 期
状态
已完成
入组人数
500
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

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •1. Spontaneous supratentorial ICH = 30 mL diagnosed using radiographic imaging (CT, CTA, etc.), with a GCS = 14 or a NIHSS = 6. Six-hour clot size equal to the most previous clot size (within 5 mL) as determined by additional CT scans at least 6 hours apart using the ABC/2 method.
  • •2. Symptoms less than 24 hours prior to diagnostic CT (dCT) scan (an unknown time of onset is exclusionary).
  • •3. Intention to initiate surgery between 12 and 72 hours after dCT. First dose can be given within 76 hours after dCT (delays for post surgical stabilization of catheter bleeding or because of unanticipated surgical delay are acceptable with approved waiver from the CCC).
  • •4. SBP < 180 mmHg sustained for six hours recorded closest to the time of randomization.
  • •5. Historical Rankin score of 0 or 1.
  • •6. Age = 18 and = 80.

排除标准

  • •1. Infratentorial hemorrhage. Intraventricular hemorrhage requiring treatment with extraventricular drainage (obstruction of third and fourth ventricles). Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and nonreactive pupils. Other (supranuclear) gaze abnormalities are not exclusions. Note: Patients with a posterior fossa ICH or cerebellar hematomas are ineligible. Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS = 4. Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease diagnosed with radiographic imaging. Patients with unstable mass or evolving intracranial compartment syndrome.
  • •2. Platelet count < 100,000, INR > 1.4, or an elevated prothrombin time (PT) or activated partial thromboplastin time (aPTT). Any irreversible coagulopathy or known clotting disorder. Inability to sustain INR = 1.4 using short and long active procoagulants (such as but not limited to NovoSeven, FFP, and/or vitamin K). Subjects requiring long-term anticoagulation 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. Use of Dabigatran prior to symptom onset.
  • •3. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.
  • •4. 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.
  • •5. Positive urine or serum pregnancy test in premenopausal female subjects without a documented history of surgical sterilization.
  • •6. Allergy/sensitivity to rtPA. Prior enrollment in the study. Planned or simultaneous participation (between screening and Day30) in another interventional medical investigation or clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving an intervention are eligible.
  • •7. Subjects who are not expected to survive to the day 365 visit due to comorbidities and/or are DNR/DNI status prior to randomization are excluded. Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease. Patients with a mechanical heart valve. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  • •8. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • •9. In the investigator's opinion, the patient is unstable and would benefit from a specific intervention rather than
  • •supportive care plus or minus MIS+rtPA removal of the ICH.
  • •10. Inability or unwillingness of subject or legal gua

研究者

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