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Completed

NCT Number: NCT02052544

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

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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Key information

Conditions

Thromboembolic Events Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsche Klinik für Diagnostik, Wiesbaden, Hesse, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall Sensitivity and Specificity of Pefakit and Hemosil.

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

dsm-firmenich Switzerland AG

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 3, 2014
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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