Post-Marketing Study to Assess Complication Rates of Oncology Patients With Ports and Peripheral IVs (VEINSFORLIFE)

June 6, 2016 updated by: C. R. Bard

A Prospective, Multi-centered Study to Assess the Complication Rates of Oncology Patients Accessed With Peripheral Intravenous Lines Versus Implantable Ports for Chemotherapy Administration

This study is to collect current information on complications rates of subjects undergoing chemotherapy administration through Ports and peripheral IVs.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

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
    • Illinois
      • Quincy, Illinois, United States, 62301
        • Quincy Medical Group
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Willis Knighton Cancer 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

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All subjects who are currently undergoing or has had infusional cancer therapy (solid tumor or hematologic) through a Bard PORT with a distally-valved catheter/open-ended catheter or infusion through a Peripheral IV

Description

Inclusion Criteria:

  • Male or female, age ≥ 21 years
  • Subject is currently undergoing or has had infusional cancer therapy (solid tumor or hematologic) through a Bard PORT with a distally-valved catheter/open-ended catheter or infusion through a PIV
  • Subject had a chemotherapy regimen consisting of a vesicant and/or irritant
  • Subject has signed an Informed Consent Form (ICF) or has had an ICF signed by the subject's legally authorized representative

Exclusion Criteria:

  • Subject has/had an implanted non Bard PORT

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

Cohorts and Interventions

Group / Cohort
Port
Subjects receiving chemotherapy through a port
Peripheral Intravenous (PIV) Lines
Subjects receiving chemotherapy through a peripheral IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of adverse events in subjects undergoing chemotherapy administration through PORTs and PIVs.
Time Frame: Through end of chemotherapy, up to 3 years
Subjects medical records will be retrospectively reviewed from present day back to January 1, 2008 to assess for complications
Through end of chemotherapy, up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The average number of accesses during course of treatment (i.e. - chemotherapy administration, CTs, blood draws, TPN, etc.)
Time Frame: Through end of chemotherapy, up to 3 years
Subjects medical records will be retrospectively reviewed from present day back to January 1, 2008 to assess for complications
Through end of chemotherapy, up to 3 years
The rate of Vascular Access Device conversion from Peripheral IV to PORT
Time Frame: Through end of chemotherapy, up to 3 years
Subjects medical records will be retrospectively reviewed from present day back to January 1, 2008 to assess for complications
Through end of chemotherapy, up to 3 years
The average time of vascular access device conversion from Peripheral IV to PORT
Time Frame: Through end of chemotherapy, up to 3 years
Subjects medical records will be retrospectively reviewed from present day back to January 1, 2008 to assess for complications
Through end of chemotherapy, up to 3 years

Collaborators and Investigators

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

Sponsor

C. R. Bard

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

February 1, 2014

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

June 6, 2016

First Posted (ESTIMATE)

June 8, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPV-13-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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