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

C. R. Bard2 sites in 1 country300 target enrollmentFebruary 2014

ConditionsPORTs/Peripheral IVs Complication Rates

Overview

Phase: N/A
Intervention: Not specified
Conditions: PORTs/Peripheral IVs Complication Rates
Sponsor: C. R. Bard
Enrollment: 300
Locations: 2
Primary Endpoint: The rate of adverse events in subjects undergoing chemotherapy administration through PORTs and PIVs.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

March 2015

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

C. R. Bard

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)
The rate of Vascular Access Device conversion from Peripheral IV to PORT(Through end of chemotherapy, up to 3 years)
The average time of vascular access device conversion from Peripheral IV to PORT(Through end of chemotherapy, up to 3 years)