Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters
NCT ID: NCT00322270
Last Updated: 2008-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2006-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Alfimeprase
single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ARCA Biopharma, Inc.
INDUSTRY
Responsible Party
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Nuvelo, Inc.
Principal Investigators
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Susan Begelman, M.D.
Role: STUDY_DIRECTOR
ARCA Biopharma, Inc.
Locations
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Desert Oasis Cancer Center
Casa Grande, Arizona, United States
Cancer Research & Prevention Center
Soquel, California, United States
Bethesda Research Center
Boynton Beach, Florida, United States
Pasco Hernando Oncology Associates
Brooksville, Florida, United States
Mercy Hospital
Miami, Florida, United States
Pasco Hernando Oncology Associate
New Port Richey, Florida, United States
Medical and Surgical Specialists
Galesburg, Illinois, United States
Cancer Center at Blessing Hospital
Quincy, Illinois, United States
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, United States
Sparrow Cancer Center
Lansing, Michigan, United States
Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States
The Center for Cancer Care and Research
St Louis, Missouri, United States
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Dakota Cancer Institute
Fargo, North Dakota, United States
Gabrail Cancer Center
Canton, Ohio, United States
Hematology/Oncology Consultants, Inc.
Columbus, Ohio, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Carilion Gynecology/Oncology
Roanoke, Virginia, United States
Countries
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Other Identifiers
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HA008
Identifier Type: -
Identifier Source: org_study_id