Phase 3, multicenter, multi-national, open-label study to evaluate the safety and efficacy of alfimeprase in subjects with occluded central venous access devices (sonoma-3) - ND

VELO0 个研究点目标入组 800 人开始时间: 2007年6月5日最近更新: 2012年3月19日

研究概览

暂无简介。

•a) The subject (or legally authorized representative) must give written informed consent;
•b) Unable to withdraw 3mL of blood from a central venous access device;
•c) If previously with CathfloActivase, at least 2 hours has elapsed since the instillation of the last dose of Cathflo Activase;
•d) Hemodynamically stable;
•e) Available for follow-up assessments.
•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

•a) Inability to infuse at least 2 mL of saline through the catheter;
•b) Catheter placed <48 hours prior to detection of occlusion;
•c) Catheter used for hemodialysis or pheresis;
•d) <18 years of age;
•e) Confirmed mechanical or nonthrombotic occlusion;
•f) In the opinion of the investigator, subject is at high risk for bleeding eventus or embolic complications, or has a condition for which bleeding constitutes a significatn hazard;
•g) Increased risk of drug extravasation;
•h) Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using active contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraceptive deemed adequate by the invetigator);
•i) Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect;
•j) Participation in any other study of an investigational device, medication, biologic, or other agent within the 30 days before enrollment and until the 30 days before enrollment and until the 30-day follow up visit;
•k) Any other subject feature that in the opinion of the investigator should preclude study participation

发起方