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Completed

NCT Number: NCT00728819

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

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.

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Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tapered PICC

Device

Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins

Non-tapered PICC

Device

Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins

Primary outcomes

  1. Evidence of PICC-related Venous Thrombosis

    Time frame: 28 days, PICC removal or hospital discharge

    Number participants with vein thrombosis

Secondary outcomes

  1. Post-operative Bleeding

    Time frame: Day 1

    Post-operative bleeding

  2. Symptomatic PICC-related Venous Thrombosis

    Time frame: Procedure through 28 days

    Symptomatic PICC-related venous thrombosis

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 6, 2008
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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