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

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DSM Nutritional Products

Status

Completed

Conditions

Thromboembolic Events

Study type

Observational

Funder types

Industry

Identifiers

NCT02052544
PICT-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

123 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

123 participants in 1 patient group

Study patients
Description:
Patients receiving unfractionated heparin (UFH)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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