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

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ClinicalTrials.gov Identifier: NCT00728819
Recruitment Status : Completed
First Posted : August 6, 2008
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Venous Thrombosis Device: Tapered PICC Device: Non-tapered PICC

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters
Study Start Date : August 2008
Primary Completion Date : January 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Evidence of PICC-related venous thrombosis [ Time Frame: 28 days, PICC removal or hospital discharge ]

Secondary Outcome Measures :
  1. Difficult/failed catheter placement [ Time Frame: Day 1 ]
  2. Post-operative bleeding [ Time Frame: Day 1 ]
  3. Symptomatic PICC-related venous thrombosis [ Time Frame: Procedure through 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00728819     History of Changes
Other Study ID Numbers: 807264
First Posted: August 6, 2008    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

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

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