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We stopped inserting BioFlo ports, no more patients to recruit
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The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in BioFlo implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline.
The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in BioFlo implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline. These complications include partial or complete obstruction, infection of the central line, and/or the onset of heparin induced thrombocytopenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months |
|
| Intervention Group | Experimental | Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparinized saline catheter flush | Other | The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Occurrence of First Complete Occlusion (Blockage) | Number of Participants with Occurrence of First Complete Occlusion (Blockage) over the 1 year. The date of the first complete occlusion will be recorded. | baseline to 1 year |
| Number of Participants With Occurrence of First Partial Occlusion (Blockage) | Number of Participants with Occurrence of First Partial Occlusion (Blockage) within the 1 year. The date of the first partial occlusion will be recorded. | baseline to 1 year |
| Number of Participants Who Required CathFlo (Alteplase) to Resolve an Occlusion | Number of Participants who required CathFlo (alteplase) to resolve an Occlusion over the 1 year. The date of first CathFlo administration will be recorded. | baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Complete or Partial Occlusions | The number of complete or partial occlusions after the first occurrence will be recorded. | baseline to 1 year |
| Number of Days Catheter Remains Patent (Unobstructed) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Sanker, RN, OCN | TriHealth Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriHealth Cancer Institute Good Samaritan Infusion Center at GSH | Cincinnati | Ohio | 45220 | United States | ||
Study terminated
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months |
| FG001 |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2017 |
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|
| Saline-only catheter flush | Drug | The intervention group will have their port catheters flushed with saline only. |
|
|
The number of days from study enrollment to the first partial or complete occlusion and the number of days between incidences of partial or complete occlusion will be recorded.
| baseline to 1 year |
| Central Line-Associated Blood Stream Infection (CLABSI) | Any laboratory-confirmed blood stream infection that is considered central line associated will be recorded. | baseline to 1 year |
| Heparin-related Complication | Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded. | baseline to 1 year |
| Ambulatory Treatment Center at Bethesda North TriHealth Hospital |
| Cincinnati |
| Ohio |
| 45242 |
| United States |
| TriHealth Cancer Institute Good Samaritan Infusion Center, Medicenter | Cincinnati | Ohio | 45242 | United States |
| TriHealth Cancer Institute Good Samaritan Infusion Center, Cheviot | Cincinnati | Ohio | 45247 | United States |
| TriHealth Cancer Institute Good Samaritan Infusion Center, Anderson | Cincinnati | Ohio | 45255 | United States |
| TriHealth Cancer Institute Good Samaritan Infusion Center Butler County | Hamilton | Ohio | 45011 | United States |
| Intervention Group |
Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only. Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months |
| BG001 | Intervention Group | Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only. Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Number of Participants With Occurrence of First Complete Occlusion (Blockage) | Number of Participants with Occurrence of First Complete Occlusion (Blockage) over the 1 year. The date of the first complete occlusion will be recorded. | Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed. | Posted | baseline to 1 year |
|
| ||||||||||||||||||||||
| Primary | Number of Participants With Occurrence of First Partial Occlusion (Blockage) | Number of Participants with Occurrence of First Partial Occlusion (Blockage) within the 1 year. The date of the first partial occlusion will be recorded. | Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed. | Posted | baseline to 1 year |
|
| ||||||||||||||||||||||
| Primary | Number of Participants Who Required CathFlo (Alteplase) to Resolve an Occlusion | Number of Participants who required CathFlo (alteplase) to resolve an Occlusion over the 1 year. The date of first CathFlo administration will be recorded. | Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed. | Posted | baseline to 1 year |
|
| ||||||||||||||||||||||
| Secondary | Number of Complete or Partial Occlusions | The number of complete or partial occlusions after the first occurrence will be recorded. | Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed. | Posted | baseline to 1 year |
|
| ||||||||||||||||||||||
| Secondary | Number of Days Catheter Remains Patent (Unobstructed) | The number of days from study enrollment to the first partial or complete occlusion and the number of days between incidences of partial or complete occlusion will be recorded. | Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed. | Posted | baseline to 1 year |
|
| ||||||||||||||||||||||
| Secondary | Central Line-Associated Blood Stream Infection (CLABSI) | Any laboratory-confirmed blood stream infection that is considered central line associated will be recorded. | Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed. | Posted | baseline to 1 year |
|
| ||||||||||||||||||||||
| Secondary | Heparin-related Complication | Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded. | Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed. | Posted | baseline to 1 year |
|
|
13 months
Plan was to report adverse events to IRB and discuss at study team meeting monthly.
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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 | Control Group | Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months | 0 | 13 | 0 | 13 | 0 | 13 |
| EG001 | Intervention Group | Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only. Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nurse Researcher | TriHealth | 513-569-6191 | Rachel_Baker2@trihealth.com |
| Apr 8, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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| >=65 years |
|
| Male |
|
| Asian |
|
| 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 |
|
| Unknown or Not Reported |
|