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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-05-31

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.

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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.

Conditions

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Thromboembolic Events

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Study patients

Patients receiving unfractionated heparin (UFH)

No interventions assigned to this group

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No