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

Primary Purpose

Venous Thrombosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tapered PICC
Non-tapered PICC
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thrombosis focused on measuring Inpatients, Requiring, DL PICC, Access, Medications, Blood

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Tapered PICC

Non-tapered PICC

Outcomes

Primary Outcome Measures

Evidence of PICC-related Venous Thrombosis
Number participants with vein thrombosis

Secondary Outcome Measures

Post-operative Bleeding
Post-operative bleeding
Symptomatic PICC-related Venous Thrombosis
Symptomatic PICC-related venous thrombosis

Full Information

First Posted
July 31, 2008
Last Updated
March 30, 2018
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00728819
Brief Title
Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters
Official Title
Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis
Keywords
Inpatients, Requiring, DL PICC, Access, Medications, Blood

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
339 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Tapered PICC
Arm Title
2
Arm Type
Active Comparator
Arm Description
Non-tapered PICC
Intervention Type
Device
Intervention Name(s)
Tapered PICC
Intervention Description
Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Intervention Type
Device
Intervention Name(s)
Non-tapered PICC
Intervention Description
Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Primary Outcome Measure Information:
Title
Evidence of PICC-related Venous Thrombosis
Description
Number participants with vein thrombosis
Time Frame
28 days, PICC removal or hospital discharge
Secondary Outcome Measure Information:
Title
Post-operative Bleeding
Description
Post-operative bleeding
Time Frame
Day 1
Title
Symptomatic PICC-related Venous Thrombosis
Description
Symptomatic PICC-related venous thrombosis
Time Frame
Procedure through 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxim Itkin, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24268631
Citation
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):85-91.e1. doi: 10.1016/j.jvir.2013.10.009. Epub 2013 Nov 21.
Results Reference
result

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

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