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

Pursuit Vascular

Status: Completed

Conditions: End Stage Renal Disease (ESRD)

Treatments: Device: ClearGuard HD end cap

Study type: Interventional

Funder types: Industry

Identifiers

NCT02604264

CLP-0001

Details and patient eligibility

About

To assess positive blood cultures (PBCs) in hemodialysis central venous catheter (CVC) patients using two FDA cleared devices: ClearGuard HD end caps compared to conventional end caps.

Enrollment: 2,912 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients dialyzing with a central venous catheter

Exclusion criteria

• Known allergy to chlorhexidine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,912 participants in 2 patient groups

ClearGuard HD end cap

Active Comparator group

Description:

Treatment

Treatment:

Device: ClearGuard HD end cap

Standard hemodialysis end cap

No Intervention group

Description:

Control