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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01578993
Recruitment Status : Completed
First Posted : April 17, 2012
Results First Posted : June 24, 2014
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Teleflex

Study Description
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Brief Summary:
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.

Condition or disease
Adult Patients With Peripherally Inserted Central Catheters

Study Design
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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase IV, Prospective Clinical Evaluation of Complications Related to the Use of Peripherally Inserted Central Catheters (PICC) - An Observational Baseline Multicenter Study.
Study Start Date : August 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : October 2013
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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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): NCT01578993


Locations
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United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Teleflex
More Information
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Responsible Party: Teleflex
ClinicalTrials.gov Identifier: NCT01578993    
Other Study ID Numbers: S-PICC 2012-01
First Posted: April 17, 2012    Key Record Dates
Results First Posted: June 24, 2014
Last Update Posted: March 16, 2016
Last Verified: May 2014