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

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Subjects receiving a continuous infusion with UFH
Subjects who have given written informed consent (unless written informed consent is waived by local regulations or local EC/IRB)

Exclusion Criteria

Subjects treated with any other anticoagulants other than UFH
Subjects who have been undergoing fibrinolytic therapy within the previous 4 weeks
Subjects who are known to have a congenital bleeding disorder
Subjects known to present unexplained prolongations of clotting time
Subjects known to have coagulation factor deficiencies
Patient participating or who has participated within one month from enrolment in another investigational study

Primary Outcome Measures

Name	Time	Method
Overall Sensitivity and Specificity of Pefakit and Hemosil.	within 2 - 4 days	Sensitivity is the proportion of positive cases identified as positive. Specificity is the proportion of negative cases identified as negative. The Sensitivity and Specificity of Pefakit and Hemosil were calculated for the overall study population and separately for each of the three medical centers. Sensitivity and Specificity of Pefakit and Hemosil were each assessed relative to the reference method (Biophen)

Secondary Outcome Measures

Name	Time	Method

Locations (3): Cantonal Hospital -Institue for Clinical Chemistry and hematology
🇨🇭
St. Gallen, Switzerland
Deutsche Klinik für Diagnostik
🇩🇪
Wiesbaden, Hessen, Germany
University of Oklahoma Health Sciences Center
🇺🇸
Oklahoma, Oklahoma, United States