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The study will collect use data of the Becton Dickinson (BD) PureHub™ Disinfecting Cap in combination with needle-free connectors, which are attached to vascular access devices (VAD).
This is a multi-center, prospective observational study of a minimum of 150 study participants who have vascular access devices (VADs) with needle-free connectors as part of their routine medical care.
Patients will be followed from the time of enrollment through the duration of VAD therapy or 45 days post enrollment date, whichever comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Cohort | Other | All patients who receive a VAD as standard of care in combination with needle-free connectors. A BD PureHub™ Disinfecting Cap will be placed on each eligible needle-free connector and all attachments/removals incl. reason for change will be documented up to 45 days post-enrollment date. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD PureHub™ Disinfecting Cap Placements: Attachments/removals | Device | Attachment/Removals of BD PureHub™ Disinfecting Cap |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector |
| Up to 45 days post-enrollment date |
| Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events. | Rate of device-related adverse events | Up to 45 days post-enrollment date |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna | Vienna | Austria | ||||
| UZA |
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| ID | Title | Description |
|---|---|---|
| FG000 | General Cohort | All patients who receive a VAD as standard of care in combination with needle-free connectors. A BD PureHub™ Disinfecting Cap will be placed on each eligible needle-free connector and all attachments/removals incl. reason for change will be documented up to 45 days post-enrollment date. BD PureHub™ Disinfecting Cap Placements: Attachments/removals: Attachment/Removals of BD PureHub™ Disinfecting Cap |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2022 | Mar 13, 2024 |
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| Antwerp |
| Belgium |
| Azienda Ospedaliera Universitaria Careggi | Florence | Italy |
| Hospital Universitario de A Coruña | A Coruña | Spain |
| Hospital Universitari Arnau de Vilanova | Valencia | Spain |
| COMPLETED |
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| NOT COMPLETED |
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Enrolled: All participants who signed the ICF Evaluable : All enrolled participants who had at least 1 BD PureHub™ Disinfecting Cap applied.
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| ID | Title | Description |
|---|---|---|
| BG000 | General Cohort | All patients who receive a VAD as standard of care in combination with needle-free connectors. A BD PureHub™ Disinfecting Cap will be placed on each eligible needle-free connector and all attachments/removals incl. reason for change will be documented up to 45 days post-enrollment date. BD PureHub™ Disinfecting Cap Placements: Attachments/removals: Attachment/Removals of BD PureHub™ Disinfecting Cap |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector |
| The primary objective was to assess the rate of select performance measures (attachment success rate & removal success rate) of the BD PureHub™ Disinfecting Caps on swabbable NFC when used in a clinical environment. | Posted | Number | 95% Confidence Interval | percentage of attachment success rate | Up to 45 days post-enrollment date |
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| Primary | Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events. | Rate of device-related adverse events | AEs in the Enrolled Population | Posted | Number | participants | Up to 45 days post-enrollment date |
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Participants were followed from the time of enrollment until one week post VAD therapy, department/hospital discharge or 45 days post enrollment date, whichever came first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | General Cohort | All patients who receive a VAD as standard of care in combination with needle-free connectors. A BD PureHub™ Disinfecting Cap will be placed on each eligible needle-free connector and all attachments/removals incl. reason for change will be documented up to 45 days post-enrollment date. BD PureHub™ Disinfecting Cap Placements: Attachments/removals: Attachment/Removals of BD PureHub™ Disinfecting Cap | 2 | 157 | 2 | 157 | 0 | 157 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | A 72-year-old male participant died as an aggravation of his oncological disease shortly after enrollment in the study. |
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| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | a 77-year-old male participant who died due to respiratory insufficiency after a long chronical disease. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephan Hofmann | Becton, Dickinson and Company | +49 160 105 3421 | Stephan.Hofmann@bd.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2023 | Mar 13, 2024 | SAP_001.pdf |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Italy |
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| Spain |
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