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

Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728819
• Other study ID #: 807264
• Status: Completed
• Phase: N/A
• First received: July 31, 2008
• Last updated: March 30, 2018
• Start date: August 2008
• Est. completion date: August 2011

Study information

• Verified date: March 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: August 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

Device:
• Tapered PICC
Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
• Non-tapered PICC
Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

Itkin M, Mondshein JI, Stavropoulos SW, Shlansky-Goldberg RD, Soulen MC, Trerotola SO. Peripherally inserted central catheter thrombosis--reverse tapered versus nontapered catheters: a randomized controlled study. J Vasc Interv Radiol. 2014 Jan;25(1):85-9 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of PICC-related Venous Thrombosis	Number participants with vein thrombosis	28 days, PICC removal or hospital discharge
Secondary	Post-operative Bleeding	Post-operative bleeding	Day 1
Secondary	Symptomatic PICC-related Venous Thrombosis	Symptomatic PICC-related venous thrombosis	Procedure through 28 days