PORTs/Peripheral IVs Complication RatesVEINSFORLIFENCT02792764
Post-Marketing Study to Assess Complication Rates of Oncology Patients With Ports and Peripheral IVs
An observational study of PORTs/Peripheral IVs Complication Rates, run by C. R. Bard at 2 sites in United States.
Trial summary
This study is to collect current information on complications rates of subjects undergoing chemotherapy administration through Ports and peripheral IVs. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- PORTs/Peripheral IVs Complication Rates
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects who are 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 Peripheral IV
Who may be able to join
- 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
Who cannot join
- Subject has/had an implanted non Bard PORT
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Quincy Medical Group
Quincy, Illinois, 62301
Willis Knighton Cancer Center
Shreveport, Louisiana, 71103
About this study
Official 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
This study is to collect current information on complications rates of subjects undergoing chemotherapy administration through Ports and peripheral IVs.
- Conditions
- PORTs/Peripheral IVs Complication Rates
- Keywords
- port, peripheral intravenous lines, oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Port | Subjects receiving chemotherapy through a port | |
| Peripheral Intravenous (PIV) Lines | Subjects receiving chemotherapy through a peripheral IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through end of chemotherapy, up to 3 years
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Through end of chemotherapy, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PORTs/Peripheral IVs Complication RatesStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792764
- Sponsor's protocol ID
- BPV-13-003
- Acronym
- VEINSFORLIFE
- Status last verified
- Feb 2016
- First submitted
- 15 Apr 2014
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02792764
- Acronym / sponsor ID
- VEINSFORLIFE / BPV-13-003
- Conditions
- PORTs/Peripheral IVs Complication Rates
- Keywords
- port, peripheral intravenous lines, oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to collect current information on complications rates of subjects undergoing chemotherapy administration through Ports and peripheral IVs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Port | – | –Subjects receiving chemotherapy through a port |
| Peripheral Intravenous (PIV) Lines | – | –Subjects receiving chemotherapy through a peripheral IV |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who are 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 Peripheral IV
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Subject has/had an implanted non Bard PORT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
The rate of Vascular Access Device conversion from Peripheral IV to PORT
Time frame: Through end of chemotherapy, up to 3 years
The average time of vascular access device conversion from Peripheral IV to PORT
Time frame: Through end of chemotherapy, up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PORTs/Peripheral IVs Complication Rates, run by C. R. Bard at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of adverse events in subjects undergoing chemotherapy administration through PORTs and PIVs. (time frame: Through end of chemotherapy, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.