Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters
Thrombosis, Venous Thrombosis, Catheter Occlusion
About this trial
This is an interventional treatment trial for Thrombosis focused on measuring Occluded Central Venous Access Devices, Occluded Catheters, Thrombosis, thrombosis, catheter, alfimeprase, thrombotic occlusion, thrombosis, CVAD, thrombosis, catheters
Eligibility Criteria
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
Sites / Locations
- Desert Oasis Cancer Center
- Cancer Research & Prevention Center
- Bethesda Research Center
- Pasco Hernando Oncology Associates
- Mercy Hospital
- Pasco Hernando Oncology Associate
- Medical and Surgical Specialists
- Cancer Center at Blessing Hospital
- Kalamazoo Hematology and Oncology
- Sparrow Cancer Center
- Comprehensive Cancer Care Clinic
- The Center for Cancer Care and Research
- UMDNJ-Robert Wood Johnson Medical School
- Dakota Cancer Institute
- Gabrail Cancer Center
- Hematology/Oncology Consultants, Inc.
- Texas Oncology, P.A.
- Carilion Gynecology/Oncology