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

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ClinicalTrials.gov Identifier: NCT00073515
Recruitment Status : Completed
First Posted : November 25, 2003
Last Update Posted : February 3, 2010
Sponsor:
Information provided by:
ARCA Biopharma, Inc.

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.

Condition or disease Intervention/treatment Phase
Catheters, Indwelling Drug: Alfimeprase Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Alfimeprase for Restoring Function in Occluded Central Venous Catheters




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073515


Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Sponsors and Collaborators
ARCA Biopharma, Inc.

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ClinicalTrials.gov Identifier: NCT00073515     History of Changes
Other Study ID Numbers: HA003
NuCath-1
First Posted: November 25, 2003    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: June 2005

Keywords provided by ARCA Biopharma, Inc.:
central venous access device
thrombosis
central venous catheter
thrombolysis
fibrinolysis