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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Semprus BioSciences, Inc.
ClinicalTrials.gov Identifier:
NCT01578993
First received: April 12, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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
Adult Patients With Peripherally Inserted Central Catheters

Study Type: Observational
Study Design: 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.

Further study details as provided by Semprus BioSciences, Inc.:

Primary Outcome Measures:
  • Rate of PICC Line Occlusions [ Time Frame: Insertion to Removal / maximum 3 months ] [ Designated as safety issue: No ]
    The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.


Enrollment: 101
Study Start Date: August 2012
Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578993

Locations
United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Semprus BioSciences, Inc.
  More Information

No publications provided

Responsible Party: Semprus BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT01578993     History of Changes
Other Study ID Numbers: S-PICC 2012-01
Study First Received: April 12, 2012
Results First Received: May 21, 2014
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014