NCT00307515已完成3 期
A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding During Retroperitoneal or Intra-Abdominal Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 16
- 主要终点
- Hemostatic success within 10 minutes.
研究概览
简要总结
A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.
详细描述
The time it will take to stop bleeding will be measured and compared between patients who are treated with fibrin sealant 2 to those who are treated with Surgicel®.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female subjects requiring non-emergent retroperitoneal or intra-abdominal surgical procedures
- •Presence of an appropriate soft-tissue target bleeding site (challenging bleeding site for which topical hemostatic adjuncts might typically be used) as identified intra-operatively by the surgeon
- •Subjects must be willing to participate in the study and provide written informed consent
排除标准
- •Subjects undergoing emergency surgery
- •Parenchymal or anastomotic bleeding sites will not be considered for randomization
- •Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
- •Subjects with known intolerance to blood products or to one for the components of the study product
- •Subjects unwilling to receive blood products
- •Subjects with known autoimmune immunodeficiency diseases (including known HIV
- •Subjects who are known, current alcohol and/or drug abusers
- •Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
- •Female subjects who are pregnant or nursing
研究组 & 干预措施
1
Experimental
Fibrin Sealant 2 (FS2)
干预措施: Fibrin Sealant 2 (FS2) (Drug)
2
Active Comparator
Oxidized Regenerated Cellulose (Surgicel)
干预措施: Oxidized Regenerated Cellulose (Surgicel) (Device)
结局指标
主要结局
Hemostatic success within 10 minutes.
时间窗: Intraoperative
次要结局
- Absence of bleeding at pre-defined time points within 10 minutes(Intraoperative)
- Incidence of treatment failures(Intraoperative)
- Incidence of potential bleeding-related complications(24 hr prior to discharge, Day 7-14)
- Adverse events(Intraoperative, 24 hr prior to discharge, Day 7-14)
研究者
研究点 (16)
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