CTRI/2009/091/000251已完成2 期
Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic Stroke
Gennova Biopharmaceuticals Limited Pune0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
入选标准
- •1. Ischemic stroke with serious measurable deficit on National Institute of Health Stroke Scale (NIHSS)
- •2. Treatment within 3 hours of stroke onset
- •3. Age 18 to 75 years
- •4. Patient or legally acceptable representative willing to give informed consent before study procedure
排除标准
- •1. Minor stroke symptoms or major symptoms rapidly improving
- •2. Intracranial hemorrhage on pretreatment head computerised tomography (CT) scan
- •3. Clinical presentation suggesting subarachnoid haemorrhage
- •4. Pregnancy
- •5. Known bleeding diathesis and/or platelet count < 100 000 mm3
- •6. Patient taking oral anticoagulants.
- •7. Patients who have received heparin within 48 hours
- •8. Major surgery or serious trauma within 14 days; serious head trauma within 3 months
- •9. Gastrointestinal or urinary tract hemorrhage within 21 days
- •10. Arterial puncture at a noncompressible site or lumbar puncture within 7 days
- •11. Uncontrolled baseline hypertension ( >185/110 mm Hg)
- •12. Clinical stroke within 3 months or history of intracranial hemorrhage
- •13. Myocardial infraction in past 30 days
- •14. Other serious medical illness likely to interfere with treatment or treatment might adversely affect that illness
- •15. Seizure at stroke onset
- •16. Confounding pre-existent neurological or psychiatric disease
- •17. Any other investigational drug within 14 days
- •18. Large areas (greater than one lobe) of obvious low density on baseline head CT scan
- •19. Unlikely to complete the protocol follow-up
- •20. Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study.
研究者
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