The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.
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 of study drug. Secondary Outcomes: The ability to withdraw at least 3 mL of blood and infuse at least 5 mL of sterile saline through the occluded catheter lumen at 30 minutes following a single instillation of study drug and at 30 minutes following a second instillation of study drug if patency is not restored within 30 minutes of the first instillation. Safety: * Adverse events * Major bleeding events * Change in laboratory values.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Corvallis Clinic
Corvallis, Oregon, United States
Catheter function restoration at fifteen minutes after initial instillation of study drug.
Time frame: 15 minutes
Catheter function restoration at 30 minutes after initial instillation of study drug.
Time frame: 30 minutes
Catheter function restoration at 30 minutes after second dose instillation of study drug if patency was not restored after first dose.
Time frame: additional 30 minutes
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