CTRI/2016/07/007115已完成4 期
Safety and Efficacy of Axiostat® hemostatic dressing on radial access after percutaneous procedure
Axio Biosolutions Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Age greater than or equal to 18 years.
- •2. Patient and/or patientâ??s legal representative and/or
- •impartial witness has/have been informed of the nature of
- •the study and agrees to its provision and has provided written
- •informed consent as approved by the Ethics Committee of the
- •investigative site.
- •3. Iatrogenic Incision
- •4. Patient who want to undergo radial intervention.
- •5. All incision size must be less than 5cm.
排除标准
- •1. Prior diagnosis of disease or medical condition affecting the
- •ability of blood to clot (e.g., hemophilia.).
- •2. Patients with known sensitivity to chitosan (shellfish)
- •used in this study.
- •3. Patients who, in the opinion of the Investigator, may not
- •complete the study for any reason, e.g. Patient requiring
- •Immediate suturing.
- •4. Patient is currently participating in an investigational drug
- •or dressing study that has not yet completed its primary endpoint interferes with procedure and assessments in this
- •5. Pregnant women.
- •6. Patients with hemorrhagic shock.
- •7. Patient having hemoglobin < 9 g/dl.
研究者
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