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

Completed

• Conditions: PORTs/Peripheral IVs Complication Rates

• Registration Number: NCT02792764
• Lead Sponsor: C. R. Bard

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-04-15
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-02
• Study First Submitted QC: 2016-06-06
• Last Update Submitted: 2016-06-06
• Study First Posted: 2016-06-08
• Last Update Posted: 2016-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Willis Knighton Cancer Center; 🇺🇸 Shreveport, Louisiana, United States

Quincy Medical Group; 🇺🇸 Quincy, Illinois, United States