Trial Outcomes & Findings for Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes (NCT NCT02923830)
NCT ID: NCT02923830
Last Updated: 2019-06-11
Results Overview
Number of Participants with Occurrence of First Complete Occlusion (Blockage) over the 1 year. The date of the first complete occlusion will be recorded.
TERMINATED
PHASE4
28 participants
baseline to 1 year
2019-06-11
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
13
|
15
|
Baseline Characteristics
Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes
Baseline characteristics by cohort
| Measure |
Control Group
n=13 Participants
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
|
Intervention Group
n=15 Participants
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.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
62.67 years
STANDARD_DEVIATION 16.72 • n=5 Participants
|
53.87 years
STANDARD_DEVIATION 15.20 • n=7 Participants
|
57.78 years
STANDARD_DEVIATION 16.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 1 yearPopulation: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
Number of Participants with Occurrence of First Complete Occlusion (Blockage) over the 1 year. The date of the first complete occlusion will be recorded.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baseline to 1 yearPopulation: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
Number of Participants with Occurrence of First Partial Occlusion (Blockage) within the 1 year. The date of the first partial occlusion will be recorded.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baseline to 1 yearPopulation: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
Number of Participants who required CathFlo (alteplase) to resolve an Occlusion over the 1 year. The date of first CathFlo administration will be recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 1 yearPopulation: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
The number of complete or partial occlusions after the first occurrence will be recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 1 yearPopulation: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 1 yearPopulation: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
Any laboratory-confirmed blood stream infection that is considered central line associated will be recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 1 yearPopulation: Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.
Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded.
Outcome measures
Outcome data not reported
Adverse Events
Control Group
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place