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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Illinois
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Quincy, Illinois, Forenede Stater, 62301
- Quincy Medical Group
-
-
Louisiana
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Shreveport, Louisiana, Forenede Stater, 71103
- Willis Knighton Cancer Center
-
-
Missouri
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Chesterfield, Missouri, Forenede Stater, 63017
- St. Luke's Hospital
-
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68150
- Southeast Nebraska Cancer Center
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Omaha, Nebraska, Forenede Stater, 68154
- Alegent Research Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Group A
Maintenance flushes at days 1-28
|
|
Group B
Maintenance flushes at days 29-56
|
|
Group C
Maintenance flushes at days 57+
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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).
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Michael McNamara, MD, Alegent Health
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BAS-11-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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