Catheter; Complications (Indwelling Catheter), Obstruction; Catheter, Infusion Catheter (Vascular)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
The intervention group will have their port catheters flushed with saline only.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to read and understand English * Has a BioFlo implanted port in place less than one (1) year * Evidence of a patent BioFlo port catheter prior to enrollment in the study * Is receiving active treatment (i.e., receiving a therapeutic drug) through the BioFlo implanted port * Current treatment protocol projected to continue for a minimum of three (3) months * Anticipates receiving care at the identified centers for 12 months following enrollment in the study * Does not receive care of BioFlo implanted port at any other facility
Exclusion criteria
* Has documented heparin platelet antibody (i.e., could not be randomized to either group) or other allergy to heparin * Receiving therapeutic dose of an anticoagulant (e.g.,warfarin, heparin, enoxaparin) * Does not meet one or more of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Occurrence of First Complete Occlusion (Blockage) | baseline to 1 year | Number of Participants with Occurrence of First Complete Occlusion (Blockage) over the 1 year. The date of the first complete occlusion will be recorded. |
| Number of Participants With Occurrence of First Partial Occlusion (Blockage) | baseline to 1 year | Number of Participants with Occurrence of First Partial Occlusion (Blockage) within the 1 year. The date of the first partial occlusion will be recorded. |
| Number of Participants Who Required CathFlo (Alteplase) to Resolve an Occlusion | baseline to 1 year | Number of Participants who required CathFlo (alteplase) to resolve an Occlusion over the 1 year. The date of first CathFlo administration will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Complete or Partial Occlusions | baseline to 1 year | The number of complete or partial occlusions after the first occurrence will be recorded. |
| Heparin-related Complication | baseline to 1 year | Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded. |
| Number of Days Catheter Remains Patent (Unobstructed) | baseline to 1 year | 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. |
| Central Line-Associated Blood Stream Infection (CLABSI) | baseline to 1 year | Any laboratory-confirmed blood stream infection that is considered central line associated will be recorded. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| 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. | 15 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 13 | 15 |
Baseline characteristics
| Characteristic | Intervention Group | Total | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 8 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 20 Participants | 7 Participants |
| Age, Continuous | 53.87 years STANDARD_DEVIATION 15.2 | 57.78 years STANDARD_DEVIATION 16.2 | 62.67 years STANDARD_DEVIATION 16.72 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 28 Participants | 13 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 15 participants | 28 participants | 13 participants |
| Sex: Female, Male Female | 11 Participants | 23 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 15 |
| other Total, other adverse events | 0 / 13 | 0 / 15 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 |
Outcome results
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.
Time frame: baseline to 1 year
Population: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
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.
Time frame: baseline to 1 year
Population: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
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.
Time frame: baseline to 1 year
Population: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
Secondary
Central Line-Associated Blood Stream Infection (CLABSI)
Any laboratory-confirmed blood stream infection that is considered central line associated will be recorded.
Time frame: baseline to 1 year
Population: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
Secondary
Heparin-related Complication
Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded.
Time frame: baseline to 1 year
Population: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
Secondary
Number of Complete or Partial Occlusions
The number of complete or partial occlusions after the first occurrence will be recorded.
Time frame: baseline to 1 year
Population: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
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.
Time frame: baseline to 1 year
Population: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.