Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters (DISTAL)
A Retrospective Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
This study is a retrospective, multi-center data collection study to support extending the maximum recommended maintenance flushing intervals in subjects who have Bard totally implanted ports with distally-valved catheters.
This study is intended to provide clinical evidence in support of extending the maximum recommended maintenance flushing interval to a time point of potentially >28 days for Bard ports with distally-valved catheters.
Reduction in the number of maintenance flushes could help alleviate the inconvenience, reduce the time and expense, and minimize the invasive nature of the maintenance flushing procedure for patients and medical institutions. Subjects will be eligible for analysis of the primary endpoint after the first successful maintenance flush of the port until (a) the first adverse event or (b) abandonment of the port.
A financial analysis will be performed on an institutional basis to determine the approximate mean cost of flushing. These costs will be extrapolated into an approximate per-patient cost for the different flushing period durations. No financial information will be collected from subject medical records. All required information will be extrapolated from site staff.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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Illinois
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Quincy, Illinois, Förenta staterna, 62301
- Quincy Medical Group
-
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Louisiana
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Shreveport, Louisiana, Förenta staterna, 71103
- Willis Knighton Cancer Center
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Missouri
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Chesterfield, Missouri, Förenta staterna, 63017
- St. Luke's Hospital
-
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Nebraska
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Lincoln, Nebraska, Förenta staterna, 68150
- Southeast Nebraska Cancer Center
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Omaha, Nebraska, Förenta staterna, 68154
- Alegent Research Center
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Male or female, age ≥ 21 years
- Subject has an implanted Bard port with a distally-valved catheter
- Subject has maintenance port flushes with heparin/heparinized saline or normal saline
- Subject is post infusional cancer therapy (solid tumor or hematologic)
- Subject has signed a HIPAA Authorization to use and disclose PHI
Exclusion Criteria:
- Subject is having port maintenance flushes/locks with citrate.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Retrospektiv
Kohorter och interventioner
Grupp / Kohort |
|---|
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Group A
Maintenance flushes at days 1-28
|
|
Group B
Maintenance flushes at days 29-56
|
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Group C
Maintenance flushes at days 57+
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The Rate of Adverse Events in Group A (1-28 Day Flushing Interval) Versus Extended Accession Intervals in Group B (29-56 Day Flushing Interval), and Group C (57+ Days).
Tidsram: 100 days
|
Subjects' maintenance flush intervals were collected by calculating the number of days since a previous flush.
A total of 1,035 maintenance flush intervals were recorded at all sites.
The numbers of flushing intervals available for analysis are 1,035 representing 49,696 patient days were recorded in 171 subjects.
|
100 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Michael McNamara, MD, Alegent Health
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BAS-11-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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