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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Subjects who meet all of the following criteria will be elligible for enrollment:

a) The subject (or legally authorized representative) must give written informed consent.
b) Unable to withdraw 3 mL of blood from a central venous access device.
c) Hemodynamically stable (i.e. no need for intravenous fluids and/or pressors to maintain blood pressure and/or urine output).
d) 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

Exclusion Criteria

Subjects who meet any of the following criteria are not eligible for enrollment:

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) Plasminogen activator (e.g. Cathflo Activase) used to treat the current episode of catheter occlusion.
e) <18 years of age.
f) Any evidence of mechanical or nonthrombic occlusion (prior to subject enrollment, the withdrawl occlusion should be confirmed after repositioning of the subject and asking the subject to move his/her extremities, cough and perform the Valsalva maneuver to minimize the chance that the occlusion is due to mechanical or nonthrombic causes. The investigator may also consider X-ray to radiographically visualise the occluded catheter to rule out obvious mechanical occlusion).
g) In the opinion of the investigator, the subject is at high risk for bleeding events or embolic complications, or has a condition for which bleeding constitutes a significant hazard.
h) Increased risk for drug extravasation.
i) Pregnant, lactating, or actively menstruating women and women of child bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator).
j) Known right-to-left cardiac shunt, patent foramen ovale, or atriallventricular septal defect.
k) Participation in any other study of an investigational device, medication, biologic or other agent within the 30 days before enrollment and until the 30 day follow-up visit.
l) Any other subject feature that in the opinion of the investigator should preclude study participation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials