ISRCTN69801104已完成未知
Thrombolysis Register of Acute Ischaemic Stroke in China
Beijing Tiantan Hospital (China)0 个研究点目标入组 330 人开始时间: 2007年8月17日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Female or male inpatients
- •2. Age 18 to 80 years
- •3. Clinical diagnosis of ischaemic stroke
- •4. Onset of symptoms within three hours prior to initiation of thrombolysis treatment
- •5. Stroke symptoms present for at least 30 minutes and has not significantly improved before treatment
- •6. Patients are willing to receive thrombolysis treatment and to give informed consent
- •7. Patients are willing and able to comply with the study protocol
排除标准
- •1. Evidence of Intracranial Haemorrhage (ICH), brain tumours, vascular malformation, aneurysm, Subarachnoid Haemorrhage (SAH) or major early infarct signs involving greater than 1/3 of Middle Cerebral Artery (MCA) territory on the Computed Tomography (CT)-scan
- •2. Severe stroke as assessed clinically (e.g. National Institutes of Health Stroke Scale [NIHSS] greater than 25) and/or by appropriate imaging techniques
- •3. Seizure at onset of stroke
- •4. Prior stroke within the last three months
- •5. Patients with any history of prior stroke and concomitant diabetes
- •6. Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
- •7. Platelet count of below 100,000/mm^3
- •8. 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 greater than 185 mmHg or diastolic blood pressure greater than or equal to 110 mmHg on three repeated measures at least 10 minutes apart
- •9. Blood glucose less than 50 or greater than 400 mg/dl
- •10. Known haemorrhagic diathesis within the last six months
- •11. Patients receiving oral anticoagulants, e.g., warfarin sodium, and International Normalised Ratio (INR) greater than 1.5
- •12. Known history of or suspected intracranial haemorrhage including subarachnoid haemorrhage
- •13. Pregnancy or lactation
- •14. Any history of severe central nervous system damage (i.e., neoplasm, aneurysm, intracranial or spinal surgery)
- •15. Haemorrhagic retinopathy, e.g., in diabetes (vision disturbances may indicate haemorrhagic retinopathy)
- •16. Bacterial endocarditis, pericarditis
- •17. 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)
- •18. Acute pancreatitis
- •19. Documented ulcerative gastrointestinal disease during the last three months
- •20. Oesophageal varices, arterial-aneurysm, arterial/venous malformation
- •21. Neoplasm with increased bleeding risk
- •22. Severe liver disease, including hepatic failure, cirrhosis, portal hypertension oesophageal varices) and active hepatitis
- •23. Major surgery or significant trauma in past 10 days
- •24. Known serious sensitivity to Alteplase
研究者
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