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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfimeprase | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter function restoration at fifteen minutes after initial instillation of study drug. | 15 minutes |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Deitcher, M.D. | ARCA Biopharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corvallis Clinic | Corvallis | Oregon | 97330 | United States |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C436755 | alfimeprase |
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