Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters
Thrombosis, Venous Thrombosis
About this trial
This is an interventional treatment trial for Thrombosis focused on measuring occluded central catheter, central venous access devices dysfunction, withdrawal occlusion, Thrombosis, Venous thrombosis
Eligibility Criteria
Inclusion Criteria: Must give written informed consent Unable to withdraw 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 of pheresis Less than 18 years of age Evidence of mechanical or nonthrombotic occlusion Receipt of any thrombolytic agent within 24 hours of randomization 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
Sites / Locations
- Corvallis Clinic