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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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

28 participants

Primary outcome timeframe

baseline to 1 year

Results posted on

2019-06-11

Participant Flow

Participant milestones

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

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

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=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=99 Participants
13 Participants
n=107 Participants
20 Participants
n=206 Participants
Age, Categorical
>=65 years
6 Participants
n=99 Participants
2 Participants
n=107 Participants
8 Participants
n=206 Participants
Age, Continuous
62.67 years
STANDARD_DEVIATION 16.72 • n=99 Participants
53.87 years
STANDARD_DEVIATION 15.20 • n=107 Participants
57.78 years
STANDARD_DEVIATION 16.20 • n=206 Participants
Sex: Female, Male
Female
12 Participants
n=99 Participants
11 Participants
n=107 Participants
23 Participants
n=206 Participants
Sex: Female, Male
Male
1 Participants
n=99 Participants
4 Participants
n=107 Participants
5 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
13 Participants
n=99 Participants
15 Participants
n=107 Participants
28 Participants
n=206 Participants
Region of Enrollment
United States
13 participants
n=99 Participants
15 participants
n=107 Participants
28 participants
n=206 Participants

PRIMARY outcome

Timeframe: baseline to 1 year

Population: 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 year

Population: 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 year

Population: 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 year

Population: 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 year

Population: 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 year

Population: 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 year

Population: 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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intervention Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nurse Researcher

TriHealth

Phone: 513-569-6191

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place