NCT00728819

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
339

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

April 27, 2018

Completed
Last Updated

April 27, 2018

Status Verified

March 1, 2018

Enrollment Period

2.4 years

First QC Date

July 31, 2008

Results QC Date

March 30, 2018

Last Update Submit

March 30, 2018

Conditions

Venous Thrombosis

Keywords

InpatientsRequiringDL PICCAccessMedicationsBlood

Outcome Measures

Primary Outcomes (1)

  • Evidence of PICC-related Venous Thrombosis

    Number participants with vein thrombosis

    28 days, PICC removal or hospital discharge

Secondary Outcomes (2)

  • Post-operative Bleeding

    Day 1

  • Symptomatic PICC-related Venous Thrombosis

    Procedure through 28 days

Study Arms (2)

1

ACTIVE COMPARATOR

Tapered PICC

Device: Tapered PICCDevice: Non-tapered PICC

2

ACTIVE COMPARATOR

Non-tapered PICC

Device: Non-tapered PICC

Interventions

Tapered PICCDEVICE

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

1
Non-tapered PICCDEVICE

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

12

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related 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):85-91.e1. doi: 10.1016/j.jvir.2013.10.009. Epub 2013 Nov 21.

    PMID: 24268631RESULT

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Associate Professor of Radiology
Organization
Penn Medicine
ITKINMAX@GMAIL.COM
2156627892

Study Officials

  • Maxim Itkin, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 6, 2008

Study Start

August 1, 2008

Primary Completion

January 1, 2011

Study Completion

August 1, 2011

Last Updated

April 27, 2018

Results First Posted

April 27, 2018

Record last verified: 2018-03

Locations

US(1)