ISRCTN12033002已完成不适用
Imaging-based Thrombolysis trial in Acute Ischemic Stroke-II
Beijing Tiantan Hospital (China)0 个研究点目标入组 200 人开始时间: 2007年10月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •For patients within 3 hrs time-windows, the only inclusion criterion for rt-PA (IV) thrombolysis is to satisfy the product instruction of rt-PA. The following are the inclusion criteria for patients within 3-9 hrs time-windows:
- •1. Female or male inpatients
- •2. Age 18-80 years
- •3. Clinical diagnosis of ischaemic stroke
- •4. Onset of symptoms within 3-9 hours prior to initiation of thrombolysis treatment
- •5. Stroke symptoms present for at least 30 minutes and has not significantly improved before treatment
- •6. The National Institute of Health Stroke Scale (NIHSS) score of greater or equal to 4
- •7. m-CT screening to be started within 8.5 hrs after stroke onset
- •8. Perfusion abnormality of CT scan >2cm in diameter involving hemisphere
- •9. CT perfusion/CTA source image mismatch greater than or equal to 20%
- •10. CTA shows occlusion or significant stenosis of large vessels (Thrombolysis in Cerebral Ischemia [TICI] grade is 0 or 1)
- •11. Patients are willing to receive thrombolysis treatment and to give informed consent
- •12. Patients are willing and able to comply with the study protocol
排除标准
- •For patients within 3 hrs time-windows, the only exclusion criterion for rt-PA (IV) thrombolysis is to satisfy the product instruction of rt-PA. The following are the exclusion criteria for patients within 3-9 hrs time-windows:
- •1. Evidence of IntraCranial Haemorrhage (ICH), brain tumors, vascular malformation, aneurysm, SubArachnoid Hemorrhage (SAH)
- •2. Major infarct involving >1/3 of MCA territory on the CTA-SI
- •3. Presenting obvious neurologic deficits because of past stroke (modified Rankin Scale [mRS] >2)
- •4. Severe stroke as assessed clinically (e.g. NIHSS >25) and/or by appropriate, magnetic imaging techniques
- •5. Seizure at onset of stroke
- •6. Prior stroke within the last 3 months
- •7. Patients with any history of prior stroke and concomitant diabetes
- •8. Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
- •9. Platelet count of below 100,000/mm3.
- •10. Uncompensated hypertension at study entry or hypertension requiring aggressive treatment to reduce blood pressure to nonhypertensive limits. Uncompensated hypertension is defined as systolic blood pressure >185 mm Hg or diastolic blood pressure >=110 mm Hg on 3 repeated measures at least 10 minutes apart
- •11. Blood glucose <50 or >400 mg/dl
- •12. Known haemorrhagic diathesis within the last 6 months
- •13. Patients receiving oral anticoagulants, e.g. warfarin sodium, and coagulant response time (INR) >1.5
- •14. Known history of or suspected intracranial haemorrhage including subarachnoid haemorrhage
- •15. Pregnancy or lactation
- •16. Any history of severe central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
- •17. Haemorrhagic retinopathy,e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy)
- •18. Bacterial endocarditis, pericarditis
- •19. Prolonged traumatic external heart massage, or recent (less than 10 days) obstetrical delivery or recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture)
- •20. Acute pancreatitis
- •21. Documented ulcerative gastrointestinal disease during the last 3 months
- •22. Oesophageal varices, arterial aneurysm, arterial/venous malformation
- •23. Neoplasm with increased bleeding risk
- •24. Severe liver disease, including hepatic failure, cirrhosis, portal hypertension, oesophageal varices and active hepatitis
- •25. Major surgery or significant trauma in past 10 days
- •26. Known serious sensitivity to alteplase
研究者
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