NCT02837744已完成不适用
Safety and Efficacy of Axiostat® Hemostatic Dressing on Radial Access After Percutaneous Procedure
Axio Biosolutions Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Time to Achieve Hemostasis
研究概览
简要总结
To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients.
详细描述
To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients who have undergone radial intervention.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater than or equal to 18 years.
- •Patient and/or patient'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.
- •Iatrogenic puncture
- •Patient who want to undergo radial intervention.
- •All puncture size must be less than 2.5cm.
排除标准
- •Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.).
- •Patients with known sensitivity to chitosan (shellfish) used in this study.
- •Patients who, in the opinion of the Investigator, may not complete the study for any reason, e.g. Patient requiring Immediate suturing.
- •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 trial.
- •Pregnant women.
- •Patients with hemorrhagic shock.
- •Patient having hemoglobin < 9 g/dl.
结局指标
主要结局
Time to Achieve Hemostasis
时间窗: 1 Day
Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops. Unit of measurement is minutes.
次要结局
- Patient Comfort Level(1 day)
- Ease of Use of Product(Upto 2 Days)
- Number of Participants With Allergy/Skin Irritation and Hematoma Formation(Upto 2 Days)
- Quantity of Product Used(1 Day)
- Number of Patients With Re-bleeding(1 Day)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
To evaluate effect of Axiostat® to stop bleeding in patients undergoing Angiography/Angioplasty.CTRI/2016/07/007115Axio Biosolutions Pvt Ltd
已完成
不适用
Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative StudyTooth ExtractionNCT03108365Axio Biosolutions Pvt. Ltd.40
已完成
4 期
A clinical trial to study the effects Axiostat® Dressing to stop bleeding from external injury/woundCTRI/2016/07/007100Axio Biosolutions Pvt Ltd61
进行中（未招募）
不适用
Random Evaluation of Patients Who Have Had Laparoscopic Partial NephrectomyKidney CancerNCT04120805University of Chicago178
已完成
不适用
A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular SurgeryCardiac Surgical ProceduresHemorrhageNCT01639833Medtronic - MITG90