Catheter Occlusion, Thrombosis, Venous Thrombosis
Conditions
Keywords
Occluded Central Venous Access Devices, Occluded Catheters, Thrombosis, thrombosis, catheter, alfimeprase, thrombotic occlusion, thrombosis, CVAD, thrombosis, catheters
Brief summary
To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of study drug to an occluded central venous access device.
Detailed description
Further study details as provided by Nuvelo
Interventions
DRUGAlfimeprase
single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD
Sponsors
ARCA Biopharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy | up to120 minutes post study drug dosing |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, serious adverse events and bleeding events | 24 hours post dosing |
| Adverse events up to day 30 visit(day 28-45) after instillation of study drug | approximately 28-45 days post dosing |
Countries
United States
Outcome results
None listed