Trial Outcomes & Findings for Product Evaluation for the Effectiveness of the ClearGuard® HD End Cap (NCT NCT02593149)

Last Updated: 2019-02-27

Results Overview

This was calculated by dividing the cumulative number of PBCs by cumulative time at-risk as follows. The National Healthcare Safety Network (NHSN) Center for Disease Control (CDC) 21-day outpatient hemodialysis patient rule is as follows: A PBC is considered a new event and counted only if it occurred 21 days or more after a previously reported PBC in the same patient; new PBC events are based on blood cultures drawn as an outpatient or within one calendar day after a hospital admission. Following a PBC additional same-type events were counted beginning 21 days following the initial event; the CVC-days were counted during this period. The CVC-days were calculated by summing the number of days each patient was at-risk of accruing a PBC. This analysis included all subjects that participated in the study that were not otherwise censored to more accurately count CVC-days.

Recruitment status

COMPLETED

Study phase

Target enrollment

1902 participants

Primary outcome timeframe

Through the 13-month intervention period.

Results posted on

2019-02-27

Participant Flow

Baseline characteristic data were not collected for the participants in the "Intervention" Period. Baseline data were collected for the "Run-In" Period with the a priori intent of showing that baseline characteristics were similar in both arms. 9 patients were excluded due to heparin allergies prior to enrollment during the "Intervention" period.

Unit of analysis: facilities

Participant milestones

Participant milestones
Measure	Treatment ClearGuard HD End Cap ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub	Control Tego® connector with the CurosTM for Tego disinfecting port protector
Run-In STARTED	340 20	361 20
Run-In COMPLETED	304 20	323 20
Run-In NOT COMPLETED	36 0	38 0
Intervention STARTED	942 20	960 20
Intervention COMPLETED	826 20	845 20
Intervention NOT COMPLETED	116 0	115 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment ClearGuard HD End Cap ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub	Control Tego® connector with the CurosTM for Tego disinfecting port protector
Run-In Didn't use CVC for at least 21 days	36	38
Intervention Didn't use CVC for at least 21 day	116	115

Baseline Characteristics

Product Evaluation for the Effectiveness of the ClearGuard® HD End Cap

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=304 Participants ClearGuard HD End Cap ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub	Control n=323 Participants Tego® connector with the CurosTM for Tego disinfecting port protector	Total n=627 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 15.6 • n=5 Participants	62.2 years STANDARD_DEVIATION 15.5 • n=7 Participants	62.9 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	159 Participants n=5 Participants	160 Participants n=7 Participants	319 Participants n=5 Participants
Sex: Female, Male Male	145 Participants n=5 Participants	163 Participants n=7 Participants	308 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	107 Participants n=5 Participants	149 Participants n=7 Participants	256 Participants n=5 Participants
Race (NIH/OMB) White	133 Participants n=5 Participants	122 Participants n=7 Participants	255 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	24 Participants n=5 Participants	13 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	304 participants n=5 Participants	323 participants n=7 Participants	627 participants n=5 Participants

PRIMARY outcome

Timeframe: Through the 13-month intervention period.

Outcome measures

Outcome measures
Measure	Treatment n=826 Participants ClearGuard HD End Cap ClearGuard HD End Cap: The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub	Control n=845 Participants Tego® connector with the CurosTM for Tego disinfecting port protector
Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days	0.28 PBCs per 1,000 CVC-days	0.75 PBCs per 1,000 CVC-days

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Laurie Lynch, PhD

Pursuit Vascular, Inc.

Phone: 6124249006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place