NCT00154141已完成3 期
A Prospective, Randomized Controlled Study to Compare the Effects of a Fibrin Sealant (FS2) Versus Manual Compression on Haemostatic Efficacy During Vascular Surgical Procedures Utilising Polytetrafluorethylene Graft Material on an End-to-Side Femoral or Upper Extremity Vascular Access Arterial Anastomosis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 34
- 主要终点
- Attainment of hemostasis at following randomization.
研究概览
简要总结
A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single
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
- •Male and female subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g. femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using uncoated or heparin-coated PTFE grafts and polypropylene sutures (size 5-0 or 6-0) with a 1:1 needle-to-thread ratio.
- •Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the SAS.
- •Subjects must be willing to and capable of participating in the study, and provided written informed consent.
排除标准
- •Subjects undergoing re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than uncoated or heparin-coated PTFE.
- •Subjects undergoing emergency surgery.
- •Subjects with any intra-operative findings that may preclude conduct of the study procedure.
- •Subjects with known intolerance to heparin, blood products or to one of the components of the study product.
- •Subjects unwilling to receive blood products.
- •Subjects with 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 enrolment.
- •Female subjects who are pregnant or nursing.
结局指标
主要结局
Attainment of hemostasis at following randomization.
次要结局
- Attainment of hemostasis following randomization.
- Incidence of treatment failures
- Incidence of potential bleeding-related complications
- Adverse events
研究者
研究点 (34)
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