PACTR202202707050206招募中4 期
Efficacy and Safety of Tenecteplase versus Alteplase in Thrombolysis of Ischemic Stroke in developping country. (ESTATIS)
Hassan II unversity hospital0 个研究点目标入组 80 人开始时间: 2019年2月16日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
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
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Man or woman not pregnant = 18 years old.
- •- Clinical picture suggestive of a stroke
- •- <4.5h after the onset of symptoms.
- •- cerebral CT or cerebral MRI showing no hemorrhage
- •- Informed consent of the patient or his legal representative.
- •- Independent before stroke (Modified Rankin scale estimated 0-1).
排除标准
- •- Evidence of intracranial hemorrhage
- •- Other significant intracranial pathology without cerebrovascular accident likely to account for clinical presentation or risk of intracerebral hemorrhage (eg central nervous system neoplasm) in computed tomography (CT) pretreatment
- •- stroke within the previous 14 days, thrombolytic therapy within the last 14 days, or CT scan hypodensity pretreatment consistent with recent cerebral ischemia other than the presentation event
- •- systolic blood pressure greater than 185 or diastolic blood pressure greater than 110 mmHg, or which remains greater than 185 or diastolic blood pressure greater than 110 mmHg despite adequate intravenous drug management) necessary to lower the blood pressure to these limits
- •- Clinical history suggestive of subarachnoid hemorrhage, even if no blood is visible during a computed tomography (CT) scan
- •- High risk of bleeding, including major surgery, trauma or gastrointestinal or urinary hemorrhage during the previous 21 days; Arterial puncture at a non-compressible site within the previous 7 days; Extended cardiopulmonary resuscitation (> 2 minutes) in the previous 14 days; Acute pericarditis and / or subacute bacterial endocarditis; acute pancreatitis; Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis; Active peptic ulceration; History of Hemorrhagic Stroke Known Fate of Coagulation or Platelet Function (Other than Antiplatelet Therapy)
- •- Hypo- or hyperglycemia (blood glucose <2 mmol / l or> 18 mmol / l) sufficient to explain neurological symptoms; Seizure at onset of symptoms unless brain imaging identifies positive signs of significant cerebral ischemia (eg, early ischemic change with ASPECTS score <7/10)
- •- Pregnancy (for women of childbearing age, a negative pregnancy test will be required before randomization);
- •- Insufficient haemostasis:
- •o Patient on anti-vitamin K therapy and International Standard Report (INR)> 1.3
研究者
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