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

NCT ID: NCT00073515

Last Updated: 2010-02-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Catheters, Indwelling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Alfimeprase

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ARCA Biopharma, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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NuCath-1

Identifier Type: -

Identifier Source: secondary_id

HA003

Identifier Type: -

Identifier Source: org_study_id

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