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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Thromboembolic Events

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study patients<br>Patients receiving unfractionated heparin (UFH) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Sensitivity and Specificity of Pefakit and Hemosil. | 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) | within 2 - 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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determination of heparin levels, Patients, requiring, unfractionated