Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters

NCT ID: NCT00346424

Last Updated: 2008-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-12-31

Brief Summary

The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.

Detailed Description

Primary Outcomes: The ability to withdraw at least 3 ml of blood and infuse more at least 5 mL of sterile saline through the occluded catheter lumen at 15 minutes after receiving initial instillation of study drug.

Secondary Outcomes:

The ability to withdraw at least 3 mL of blood and infuse at least 5 mL of sterile saline through the occluded catheter lumen at 30 minutes following a single instillation of study drug and at 30 minutes following a second instillation of study drug if patency is not restored within 30 minutes of the first instillation.

Safety:

• Adverse events
• Major bleeding events
• Change in laboratory values.

Conditions

Thrombosis; Venous Thrombosis

Keywords

occluded central catheter; central venous access devices dysfunction; withdrawal occlusion; Thrombosis; Venous thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Alfimeprase

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must give written informed consent
• Unable to withdraw 3 mL of blood from a central venous access device
• Hemodynamically stable
• Available for follow-up assessments

Exclusion Criteria

• Inability to infuse at least 2 mL of saline through the catheter
• Catheter placed less than 48 hours prior to detection of occlusion
• Catheter used for hemodialysis of pheresis
• Less than 18 years of age
• Evidence of mechanical or nonthrombotic occlusion
• Receipt of any thrombolytic agent within 24 hours of randomization
• In the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard
• Increased risk for drug extravasation
• Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
• Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
• Participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit
• Any other subject feature that in the opinion of the investigator should preclude study participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ARCA Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Steven Deitcher, M.D.

Role: STUDY_DIRECTOR

ARCA Biopharma, Inc.

Locations

Corvallis Clinic

Corvallis, Oregon, United States

Countries

United States

Other Identifiers

HA006

Identifier Type: -

Identifier Source: org_study_id