N/A N=701 Randomized Treatment

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

End Stage Renal Disease (ESRD)

Bottom Line

View on ClinicalTrials.gov: NCT02593149 ↗

Enrolled (actual)

701

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days — 0.28; 0.75 PBCs per 1,000 CVC-days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ClearGuard HD End Cap (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pursuit Vascular, Inc.
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days	0.28; 0.75	—

Summary

To assess blood stream infections in participants using two FDA-cleared devices: ClearGuard HD end caps compared to the Tego® connector with the CurosTM for Tego disinfecting port protector.

Eligibility Criteria

Inclusion Criteria

All patients dialyzing with a central venous catheter

Exclusion Criteria

Known allergy to chlorhexidine

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02593149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.