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

C. R. Bard300 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

PORTs/Peripheral IVs Complication Rates

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (2)

Quincy Medical Group

Quincy, Illinois, United States

Willis Knighton Cancer Center

Shreveport, Louisiana, United States

Outcomes

Primary Outcomes

The rate of adverse events in subjects undergoing chemotherapy administration through PORTs and PIVs.

Subjects medical records will be retrospectively reviewed from present day back to January 1, 2008 to assess for complications

Time frame: Through end of chemotherapy, up to 3 years

Secondary Outcomes

The average number of accesses during course of treatment (i.e. - chemotherapy administration, CTs, blood draws, TPN, etc.)

Subjects medical records will be retrospectively reviewed from present day back to January 1, 2008 to assess for complications

Time frame: Through end of chemotherapy, up to 3 years

The rate of Vascular Access Device conversion from Peripheral IV to PORT

Subjects medical records will be retrospectively reviewed from present day back to January 1, 2008 to assess for complications

Time frame: Through end of chemotherapy, up to 3 years

The average time of vascular access device conversion from Peripheral IV to PORT

Subjects medical records will be retrospectively reviewed from present day back to January 1, 2008 to assess for complications

Time frame: Through end of chemotherapy, up to 3 years

Data from ClinicalTrials.gov

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