Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices - Tabular View

Tracking Information
First Received Date ^ICMJE	November 21, 2003
Last Updated Date	February 16, 2007
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00073515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices
Official Title ^ICMJE	A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Alfimeprase for Restoring Function in Occluded Central Venous Catheters
Brief Summary	This trial is for patients with a central venous catheter (a vascular access device) that is not functioning properly (unable to withdraw blood). The trial compares a new blood clot dissolving agent (alfimeprase) against the currently used treatment.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Catheters, Indwelling
Intervention ^ICMJE	Drug: Alfimeprase
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	115
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Subjects must: have a dysfunctional Central Venous Access Device (CVAD) defined as unable to withdraw 3 mL blood have had the device in place for > 48 hours be clinically stable be 18 or older give informed consent
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00073515
Responsible Party
Study ID Numbers ^ICMJE	HA003, NuCath-1
Study Sponsor ^ICMJE	ARCA Biopharma, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	ARCA Biopharma, Inc.
Verification Date	June 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP