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Completed

NCT Number: NCT02792764

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

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

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Key information

Conditions

PORTs/Peripheral IVs Complication Rates Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Quincy Medical Group, Quincy, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

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

    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

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

    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

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

    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

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

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

Acronym: VEINSFORLIFE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 8, 2016
Registry last updated
Jun 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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