NCT00658723已完成2 期
A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 11
- 主要终点
- Proportion of Subjects Achieving Hemostatic Success
研究概览
简要总结
The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.
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
- 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
- •Subjects >= 18 years of age, requiring non-emergent, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures
- •Presence of an appropriate soft tissue Target Bleeding Site (TBS) as identified intraoperatively by the surgeon
- •Subjects must be willing to participate in the study, and provide written informed consent
排除标准
- •Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
- •Subject with TBS within an actively infected field
- •Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine
- •Subjects with known intolerance to blood products or to one of the components of the study product
- •Subjects unwilling to receive blood products
- •Subjects with 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
干预措施: Fibrin Pad (Drug)
2
Active Comparator
SURGICEL™ Absorbable Hemostat
干预措施: SURGICEL™ (Device)
结局指标
主要结局
Proportion of Subjects Achieving Hemostatic Success
时间窗: Intra-operative
Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.
次要结局
- Proportion of Subjects Achieving Hemostatic Success(10 minutes)
- Incidence of Treatment Failures(Intra-operative)
- Incidence of Adverse Events That Are Potentially Related to Bleeding(Intra-operative up to 1 month (+14 days))
- Incidence of Adverse Events Potentially Related to Transfusion Exposure(Intra-operative up to 1 month (+14 days))
- Incidence of Adverse Events(30 days (+14 days))
- Incidence of Adverse Events That Are Potentially Related to Thrombotic Events(Intra-operative up to 1 month (+14 days))
- Incidence of Re-treatment(Intra-operative)
研究者
研究点 (11)
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