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

Thromboembolic Events Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Thromboembolic Events
• Thromboembolism

• NCT number: NCT02052544
• Study type: Observational
• Source: DSM Nutritional Products, Inc.
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Completion date: May 2013