NCT02052544

Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 123 (actual)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States Food and Drug Administration (FDA) 510(k) submission.

Detailed description

Standard of Care Study. Objective is to monitor the patients' heparin levels under treatment with continuous unfractionated heparin infusions. Blood samples collections (4 ml) are required routinely. A proportion of this standard sample (leftover plasma) will be used for study purposes. About three samples will be analyzed which are collected within 2 - 4 days. Time points for blood sample collections will be defined by the treating physician according the local standard of care and will be associated exclusively to clinical considerations. Results of the Pefakit® PiCT® UC assay will NOT be used to take therapeutic decisions for study subjects.

Conditions

• Thromboembolic Events

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2014-02-03
• Last updated: 2015-05-06
• Results posted: 2015-05-06

Locations

3 sites across 3 countries: United States, Germany, Switzerland