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

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

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

Conditions
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PORTs/Peripheral IVs Complication Rates

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Port<br>Subjects receiving chemotherapy through a port | |
| Peripheral Intravenous (PIV) Lines<br>Subjects receiving chemotherapy through a peripheral IV | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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.) | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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port, peripheral intravenous lines, oncology