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Clinical Trials/NCT01578993
NCT01578993CompletedNot Applicable

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

Teleflex1 site in 1 country101 target enrollmentStarted: August 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Teleflex
Enrollment
101
Locations
1
Primary Endpoint
Rate of PICC Line Occlusions

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Teleflex
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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