Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters

University of Pennsylvania1 site in 1 country339 target enrollmentAugust 2008

ConditionsVenous Thrombosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Venous Thrombosis
Sponsor: University of Pennsylvania
Enrollment: 339
Locations: 1
Primary Endpoint: Evidence of PICC-related Venous Thrombosis
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare two different marketed PICC (peripherally inserted central catheter) designs. Clotting rates, procedural bleeding and ease of catheter insertion will be compared. It is hypothesized that the non-tapered design has a lower clotting rate and is easier to place than the tapered design. Bleeding rates are expected to be about the same.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

August 2011

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All inpatients, age 18 to 90, in need of de novo central venous access with a double lumen catheter indication of \> 2 weeks
•Informed consent and HIPAA consent forms discussed and signed by patient or their authorized representative

Exclusion Criteria

•Skin related problems around the insertion site (infection, phlebitis, scars)
•History of mastectomy/axillary dissection on insertion side
•Coagulopathy with an INR of \> 2.0
•Thrombocytopenia with platelets \< 25,000 uL
•Renal insufficiency with a creatinine of \> 3.0 mg/dL
•Documented current upper extremity or central venous thrombosis
•Hypercoagulable states (protein C or S deficiency, AT-III deficiency, lupus anticoagulant)
•Catheters needed for therapy within less than an hour (emergent placement not allowing sufficient time for proper research consent and randomization)
•Patient has already been enrolled in this research study
•Life expectancy less than 1 month