NCT02677818撤回不适用
The Relationship Between Clotting Factor VIII and Bleeding Adverse Reactions in Patients Under the Therapies of Thrombolysis, Anticoagulation and Anti-platelet
Zhujiang Hospital1 个研究点 分布在 1 个国家开始时间: 2016年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The levels of FVIII are measured by enzyme-linked immuno sorbent assay.
研究概览
简要总结
The purpose of this study is to determine whether Plasma Factor VIII Levels are related to the treatment of bleeding in ischemic stroke（IS）.
详细描述
Clear cerebral infarction patients during hospitalization, treatment process, discharge and hemorrhage occurs, the stages F VIII level change and its correlation with bleeding adverse reactions. Analysis F VIII whether belong to hemorrhage occurs independent risk factors of adverse drug reactions,as well as the feasibility of predicting bleeding occurred adverse reaction index.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Guidelines prepared by the diagnostic criteria(according to the diagnostic criteria of the Fourth National Stroke Conference prepared,have been more than one times skull CT and/or MRI)was confirmed for ischemic stroke,and requires the use of antithrombotic therapy(including thrombolysis, anticoagulation, antiplatelet) patients
- •Willing and able to comply with the study protocol and visits planned
排除标准
- •At the same time the presence of other active malignancy.
- •There is known brain metastases or leptomeningeal metastases
- •Systemic active infection ( ie infection leads to body temperature ≥38 ℃)
- •The last 4 weeks there is a need drainage ascites, pleural effusion or pericardial fluid .
- •Clinically significant obstruction , pulmonary fibrosis , kidney failure , liver failure and other diseases.
- •Uncontrolled diabetes.
- •Severe / unstable angina, New York Heart Association (NYHA) class III or IV symptoms of congestive heart failure
- •there is other reason (not the antithrombotic drugs) caused by bleeding.
- •The presence of an autoimmune disease or a history of organ transplant patients require immunosuppressive therapy
- •Psychiatric presence may increase the risks associated with study participation or study drug , or may interfere with the interpretation of study results
- •Pregnant and lactating women
- •Bleeding disorders may exist on admission
- •The researchers added that the study is not appropriate to the circumstances
结局指标
主要结局
The levels of FVIII are measured by enzyme-linked immuno sorbent assay.
时间窗: one year
次要结局
未报告次要终点
研究者
研究点 (1)
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