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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00728819
First received: July 31, 2008
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Venous Thrombosis
 Device: Tapered PICC
Device: Non-tapered PICC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Evidence of PICC-related venous thrombosis [ Time Frame: 28 days, PICC removal or hospital discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Difficult/failed catheter placement [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Post-operative bleeding [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Symptomatic PICC-related venous thrombosis [ Time Frame: Procedure through 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 340
Study Start Date: August 2008
Study Completion Date: August 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Tapered PICC
 Device: Tapered PICC
Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Device: Non-tapered PICC
Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Active Comparator: 2
Non-tapered PICC
 Device: Non-tapered PICC
Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728819

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Maxim Itkin, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00728819     History of Changes
Other Study ID Numbers: 807264
Study First Received: July 31, 2008
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Inpatients
Requiring
DL PICC
 Access
Medications
Blood

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on May 21, 2013