Status:
COMPLETED
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters
Lead Sponsor:
ARCA Biopharma, Inc.
Conditions:
Thrombosis
Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.
Detailed Description
Primary Outcomes: The ability to withdraw at least 3 ml of blood and infuse more at least 5 mL of sterile saline through the occluded catheter lumen at 15 minutes after receiving initial instillation ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00346424
Start Date
September 1 2005
End Date
December 1 2006
Last Update
August 14 2008
Active Locations (1)
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1
Corvallis Clinic
Corvallis, Oregon, United States, 97330