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NCT00073515 Clinical Trial

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

Catheters, Indwelling Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00073515
Other study ID # HA003
Secondary ID NuCath-1
Status Completed
Phase Phase 2
First received November 21, 2003
Last updated February 2, 2010

Study information
Verified date June 2005
Source ARCA Biopharma, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 115
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Alfimeprase

Locations
Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
ARCA Biopharma, Inc.

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
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Completed NCT03351725 - Peripheral Venous Catheter Colonization Study
Completed NCT00272623 - Seldinger Technique Versus Venous Cut-Down for Placement of Totally Implantable Venous Access Ports N/A
Completed NCT00001518 - A Randomized Evaluation of the Effect of Routine Normal Saline Flush Versus Heparinized Saline Solution in Groshong and Groshong PICC Catheters N/A