ISRCTN47341677已完成未知
CLEAR IVH: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)
Johns Hopkins University (USA)0 个研究点目标入组 64 人开始时间: 2004年9月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
- 2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21940973 (added 11/04/2019) 2. 2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22382155 (added 11/04/2019) 3. 2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22474059 (added 11/04/2019) 4. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23370203 (added 11/04/2019) 5. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23463422 (added 11/04/2019) 6. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26228884 (added 11/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 18-75
- •2. Intraventricular catheter (IVC) placed as standard of care using less than or equal to two complete passes
- •3. Spontaneous intracerebral hemorrhage (ICH) <30 cc
- •4. Able to receive first dose within 48 hours of computed tomography (CT) scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours)
- •5. Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size + 5 cc (as determined by the (A x B x C)/2 method)
- •6. On stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of cerebrospinal fluid [CSF] flow on CT)
- •7. Systolic
- •blood pressure (SBP) <200 mmHg sustained for 6 hours
- •8. Historical Rankin of 0 or 1
排除标准
- •1. Suspected or untreated aneurysm or arterio venous malformation (AVM) (unless ruled out by angiogram or magnetic resonance angiography [MRA]/magnetic resonance imaging [MRI])
- •2. Clotting disorders
- •3. Patients with platelet count <100,000, international normalized ratio (INR) >1.7, prothrombin time (PT) >15 s, or an elevated activated partial thromboplastin time (APTT)
- •4. Pregnancy (positive pregnancy test)
- •5. Infratentorial hemorrhage (i.e. parenchymal/posterior fossa hematoma; all cerebellar hematomas are excluded)
- •6. Subarachnoid hemorrhage (SAH). (An angiogram should be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. If the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study.)
- •7. ICH enlargement during the 6-hour stabilization period (6 hours after IVC placement)
- •8. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
- •9. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g. venous cutdowns, arterial punctures) or site of recent surgical intervention
- •10. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis
- •11. Prior enrollment in the study
- •12. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •13. Participation in another simultaneous medical investigation or trial
研究者
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