Trial Outcomes & Findings for Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters (NCT NCT01586026)

Last Updated: 2016-08-23

Results Overview

Subjects' maintenance flush intervals were collected by calculating the number of days since a previous flush. A total of 1,035 maintenance flush intervals were recorded at all sites. The numbers of flushing intervals available for analysis are 1,035 representing 49,696 patient days were recorded in 171 subjects.

Recruitment status

TERMINATED

Target enrollment

171 participants

Primary outcome timeframe

100 days

Results posted on

2016-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	Group A Maintenance flushes at days 1-28	Group B Maintenance flushes at days 29-56	Group C Maintenance flushes at days 57+
Overall Study STARTED	350	414	271
Overall Study COMPLETED	350	414	271
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combined Demographics n=171 Participants Demographics of 171 subjects that contributed to final data analysis
Age, Continuous	65.7 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	160 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	168 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	171 participants n=5 Participants
Cancer Type Solid tumor	142 participants n=5 Participants
Cancer Type Hematologic	29 participants n=5 Participants
Port Access Vein Jugular	65 participants n=5 Participants
Port Access Vein Subclavian	102 participants n=5 Participants
Port Access Vein Unknown	4 participants n=5 Participants
Port Configuration Single Lumen	132 participants n=5 Participants
Port Configuration Dual Lumen	1 participants n=5 Participants
Port Configuration Unknown	38 participants n=5 Participants
Catheter Configuration 7Fr.	0 participants n=5 Participants
Catheter Configuration 8Fr.	11 participants n=5 Participants
Catheter Configuration 9.5Fr.	0 participants n=5 Participants
Catheter Configuration Unknown	160 participants n=5 Participants

PRIMARY outcome

Timeframe: 100 days

Outcome measures

Outcome measures
Measure	Group A n=350 Participants Maintenance flushes at days 1-28	Group B n=414 Participants Maintenance flushes at days 29-56	Group C n=271 Participants Maintenance flushes at days 57+
The Rate of Adverse Events in Group A (1-28 Day Flushing Interval) Versus Extended Accession Intervals in Group B (29-56 Day Flushing Interval), and Group C (57+ Days).	0 adverse events	1 adverse events	2 adverse events

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group C

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group A n=350 participants at risk Maintenance flushes at days 1-28	Group B n=414 participants at risk Maintenance flushes at days 29-56	Group C n=271 participants at risk Maintenance flushes at days 57+
Injury, poisoning and procedural complications Port/Catheter Malfunction	0.00% 0/350 • During retrospective review of subject records all defined adverse events were recorded from January 1, 2008 to date of chart review. Adverse events were assessed separately for each flushing interval, and not for each participant	0.24% 1/414 • During retrospective review of subject records all defined adverse events were recorded from January 1, 2008 to date of chart review. Adverse events were assessed separately for each flushing interval, and not for each participant	0.37% 1/271 • During retrospective review of subject records all defined adverse events were recorded from January 1, 2008 to date of chart review. Adverse events were assessed separately for each flushing interval, and not for each participant
General disorders Fractured Catheter	0.00% 0/350 • During retrospective review of subject records all defined adverse events were recorded from January 1, 2008 to date of chart review. Adverse events were assessed separately for each flushing interval, and not for each participant	0.00% 0/414 • During retrospective review of subject records all defined adverse events were recorded from January 1, 2008 to date of chart review. Adverse events were assessed separately for each flushing interval, and not for each participant	0.37% 1/271 • During retrospective review of subject records all defined adverse events were recorded from January 1, 2008 to date of chart review. Adverse events were assessed separately for each flushing interval, and not for each participant

Additional Information

Christopher DiMatteo

Bard Access Systems, Inc.

Phone: 801-522-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place