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-toSide Femoral or Upper Extremity Vascular Access Arterial Anastomosis. - FS2 in Vascular Surgery

OMRIX biopharmaceuticals Ltd0 个研究点目标入组 147 人2005年5月4日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Patients undergoing vascular surgical procedures will be included in this study. This will include patients with peripheral vascular disease and also patients with renal disease who require vascular access for dialysis.
发起方: OMRIX biopharmaceuticals Ltd
入组人数: 147
状态: 进行中（未招募）
最后更新: 6年前

暂无简介。

注册库

who.int

开始日期

2005年5月4日

结束日期

2006年3月29日

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

发起方

•1\. Male and female patients, 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 PTFE grafts, polypropylene sutures and 1:1 needle\-to\-thread ratio.
•2\. Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the study anastomosis.
•3\. Patients must be willing to and capable of participating in the study, and provide written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•Patients are excluded due to the following criteria as these may influence obtaining haemostasis: re\-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than PTFE; Patients with autoimmune immunodeficiency diseases (including known HIV); Patients who are undergoing emergency surgery will be excluded as there would be insufficient time to obtain consent; Patients with any intra\-operative findings may preclude conduct of the study procedure; In order to protect vulnerable groups, patients who are current drug or alcohol abusers will be excluded; Patients with known intolerance to heparin, blood products or to one of the components of the study products will be excluded to minimise the risk of allergic reaction; Patients who are unwilling to receive blood products are also excluded as FS2 is produced from human plasma; Patients who have participated in another investigational drug or device research study within 30 days of enrollment will also be excluded; As the safety of the product in human pregnancy has not been established, pregnant patients will be excluded from the study.