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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02792764

Acronym

VEINSFORLIFE

Enrollment

300

Registered

2016-06-08

Start date

2014-02-28

Completion date

2015-03-31

Last updated

2016-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PORTs/Peripheral IVs Complication Rates

Keywords

port, peripheral intravenous lines, oncology

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The rate of adverse events in subjects undergoing chemotherapy administration through PORTs and PIVs.	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

Secondary

Measure	Time frame	Description
The average number of accesses during course of treatment (i.e. - chemotherapy administration, CTs, blood draws, TPN, etc.)	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
The rate of Vascular Access Device conversion from Peripheral IV to PORT	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
The average time of vascular access device conversion from Peripheral IV to PORT	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

Countries

United States

Outcome results