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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 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 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 |
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| Intervention Group | Experimental | Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only. |
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| 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 First Complete Occlusion Within 1 Year | Number of participants who had a first complete occlusion (Blockage) within 1 year | baseline to 1 year |
| Number of Participants With First Partial Occlusion Within 1 Year | Number of Participants with First Partial Occlusion (Blockage) within 1 year | baseline to 1 year |
| Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year | Number of Participants with First Cathflo administration for Occlusion (Blockage) within 1 year | baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With First Complete or Partial Occlusion Within 1 Year | Number of Participants with either a First Complete or Partial Occlusion (Blockage) within 1 year | baseline to 1 year |
| Number of Participants With HIT Within 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Pelgen, BSN, RN, OCN | TriHealth Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Health Barrett Infusion Center | Cincinnati | Ohio | 45219 | United States | ||
| TriHealth Cancer Institute Good Samaritan Infusion Center at GSH |
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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 | Jan 22, 2020 |
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| Saline-only catheter flush | Other | The intervention group will have their port catheters flushed with saline only. |
|
Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded.
| baseline to 1 year |
| Cincinnati |
| Ohio |
| 45220 |
| United States |
| 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 |
| McCullough Hyde Memorial Hospital Infusion Center | Oxford | Ohio | 45056 | 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 |
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| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | 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 First Complete Occlusion Within 1 Year | Number of participants who had a first complete occlusion (Blockage) within 1 year | NOTE: 1 participant had BOTH a partial occlusion and a complete occlusion. Therefore, when adding information from Outcome Measures 1 and 2 to determine the total number of participants with either complete or partial occlusions in the "Control Group" is correct as 43 (i.e., (5+39 = 44) - 1 participant in both groups = 43 distinct participants) | Posted | Count of Participants | Participants | baseline to 1 year |
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| |||||||||||||||||||||||||||||
| Primary | Number of Participants With First Partial Occlusion Within 1 Year | Number of Participants with First Partial Occlusion (Blockage) within 1 year | NOTE: 1 participant had BOTH a partial occlusion and a complete occlusion. Therefore, when adding information from Outcome Measures 1 and 2 to determine the total number of participants with either complete or partial occlusions in the "Control Group" is correct as 43 (i.e., (5+39 = 44) - 1 participant in both groups = 43 distinct participants) | Posted | Count of Participants | Participants | baseline to 1 year |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year | Number of Participants with First Cathflo administration for Occlusion (Blockage) within 1 year | Posted | Count of Participants | Participants | baseline to 1 year |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With First Complete or Partial Occlusion Within 1 Year | Number of Participants with either a First Complete or Partial Occlusion (Blockage) within 1 year | Posted | Count of Participants | Participants | baseline to 1 year |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HIT Within 1 Year | Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded. | Posted | Count of Participants | Participants | baseline to 1 year |
|
|
1 year
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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 | 42 | 222 | 0 | 222 | 0 | 222 |
| 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. | 27 | 214 | 0 | 214 | 0 | 214 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Baker, Nurse Researcher | TriHealth | 513-569-6191 | Rachel_Baker2@trihealth.com |
| Jan 24, 2022 |
| 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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