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

Not Applicable

Completed

• Conditions: Venous Thrombosis
• Interventions: Device: Tapered PICC; Device: Non-tapered PICC

• Registration Number: NCT00728819
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-31
• Study Start: 2008-08
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-06
• Primary Completion: 2011-01
• Study Completion: 2011-08
• Status Verified: 2018-03
• Results First Submitted: 2018-03-30
• Results First Submitted QC: 2018-03-30
• Last Update Submitted: 2018-03-30
• Results First Posted: 2018-04-27
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Tapered PICC	Tapered PICC
1	Non-tapered PICC	Tapered PICC
2	Non-tapered PICC	Non-tapered PICC

Primary Outcome Measures

Name	Time	Method
Evidence of PICC-related Venous Thrombosis	28 days, PICC removal or hospital discharge	Number participants with vein thrombosis

Secondary Outcome Measures

Name	Time	Method
Symptomatic PICC-related Venous Thrombosis	Procedure through 28 days	Symptomatic PICC-related venous thrombosis
Post-operative Bleeding	Day 1	Post-operative bleeding

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States