Observational Study of Complications Related to Use of Peripherally Inserted Central Catheters (PRISM-1)

February 18, 2016 updated by: Teleflex

A Phase IV, Prospective Clinical Evaluation of Complications Related to the Use of Peripherally Inserted Central Catheters (PICC) - An Observational Baseline Multicenter Study.

The purpose of this study is to determine the rate and timing of interventions and complications related to the use of peripherally inserted central venous catheters in adult patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients necessitating insertion of a PICC for fluid, nutritional, chemotherapy or antibiotic treatment for a minimum of 14 days.

Description

Inclusion Criteria:

  • Male or Female Age > 18 years requiring central venous access
  • Ability to comply with study requirements
  • Written Informed Consent

Exclusion Criteria:

  • Previous enrollment in study
  • Current or recent upper extremity thrombosis, occlusion or stenosis
  • Previous axillary lymph node dissection
  • Skin inflammatory condition or rashes within 15 cm from insertion site
  • Pre-existing history of hypercoagulability unrelated to malignant disease
  • Participating in trial involving antithrombotic, anticoagulant or anti- infective drug therapies
  • Positive blood culture within 48 hours from planned PICC placement
  • Known, renal insufficiency with chronic creatinine levels > 1.7 mg/dl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of PICC Line Occlusions
Time Frame: Insertion to Removal / maximum 3 months
The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.
Insertion to Removal / maximum 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teleflex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

April 12, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 17, 2012

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

May 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • S-PICC 2012-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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