Clinical trial NCT00346424: Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters
Official title: Phase 3, Multicenter, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Occluded Central Venous Access Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thrombosis
Venous Thrombosis
Keywords: occluded central catheter
central venous access devices dysfunction
withdrawal occlusion
Thrombosis
Venous thrombosis
Lead sponsor: ARCA Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2006-06-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Catheter function restoration at fifteen minutes after initial instillation of study drug.
timeFrame: 15 minutes
Secondary outcomes:
measure: Catheter function restoration at 30 minutes after initial instillation of study drug.
timeFrame: 30 minutes
measure: Catheter function restoration at 30 minutes after second dose instillation of study drug if patency was not restored after first dose.
timeFrame: additional 30 minutes
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Corvallis Clinic
state: Oregon
Study officials:
affiliation: ARCA Biopharma, Inc.
name: Steven Deitcher, M.D.
role: STUDY_DIRECTOR
References: