A Prospective, Multi-Center, Randomized, Single-Blind Study to Compare the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Median Time to Achieve Hemostasis Following Application of Study Treatment.
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Inclusion Criteria:
- •Scheduled for non-emergent, hepatic surgery
- •Presence of an appropriate target bleeding site (TBS) as defined by the protocol
排除标准
- •Subject will be undergoing a laparoscopic hepatic procedure where the Hemostatic Patch will be delivered and applied through a trocar
- •In subjects with documented history of cirrhosis, subject has uncorrected platelet count <60,000 per mm³ as determined by laboratory tests performed immediately prior to surgery
- •Subject has severe coagulopathy defined as INR > 2.0
- •Subject has Total Bilirubin >2.5mg/dL
- •Subject has an active local infection at the Target Bleeding Site
- •Study procedure involves a liver transplant recipient
研究组 & 干预措施
Veriset Hemostatic Patch
Veriset Hemostatic Patch
干预措施: Veriset Hemostatic Patch (Device)
Fibrin Sealant (TachoSil®)
Fibrin Sealant (TachoSil®)
干预措施: Fibrin Sealant (TachoSil®) (Device)
结局指标
主要结局
Median Time to Achieve Hemostasis Following Application of Study Treatment.
时间窗: Intra-operative (day 1)
Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
次要结局
- Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application(Intra-operative (day 1))
- Number of Subjects With Treatment-emergent Adverse Events(Up to 30 days post surgery.)