Thrombosis, Venous Thrombosis
Conditions
Keywords
occluded central catheter, central venous access devices dysfunction, withdrawal occlusion, Thrombosis, Venous thrombosis
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 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.
Interventions
DRUGAlfimeprase
Sponsors
ARCA Biopharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Catheter function restoration at fifteen minutes after initial instillation of study drug. | 15 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Catheter function restoration at 30 minutes after initial instillation of study drug. | 30 minutes |
| Catheter function restoration at 30 minutes after second dose instillation of study drug if patency was not restored after first dose. | additional 30 minutes |
Countries
United States
Outcome results
None listed