NCT00073515

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2003

Completed
Last Updated

February 3, 2010

Status Verified

June 1, 2005

First QC Date

November 21, 2003

Last Update Submit

February 2, 2010

Conditions

Catheters, Indwelling

Keywords

central venous access devicethrombosiscentral venous catheterthrombolysisfibrinolysis

Interventions

AlfimepraseDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Location

MeSH Terms

Conditions

Thrombosis

Interventions

alfimeprase

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 21, 2003

First Posted

November 25, 2003

Last Updated

February 3, 2010

Record last verified: 2005-06

Locations

US(1)