Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters

Further study details as provided by Nuvelo

Inclusion criteria

• Must give written informed consent
• Ages 18 or older
• Unable to withdraw at least 3 mL of blood from a central venous access device
• Hemodynamically stable
• Available for follow-up assessments

Exclusion criteria

• Inability to infuse at least 2 mL of saline through the catheter
• Catheter placed less than 48 hours prior to detection of occlusion
• Catheter used for hemodialysis or pheresis
• Previous treatment with plasminogen activator for current episode of catheter occlusion
• Less than 18 years of age
• Any evidence of mechanical or nonthrombotic occlusion
• In the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard
• Increased risk for drug extravasation
• 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)
• Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
• Participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit
• Any other subject feature that in the opinion of the investigator should preclude study participation