Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005895

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00005895
  •   2015/02/20
  •   2014/01/17
  •   no
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Secondary IDs

  •   NCT02052544  (ClinicalTrials.gov)
  •   PICT-01  (DSM Nutritional Products, Inc.)
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Health Condition or Problem studied

  •   Thromboembolic Events
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Clotting times versus UFH concentrations.; time frame: within 2 - 4 days; 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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Secondary Outcome

[---]*

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Countries of Recruitment

  •   United States
  •   Germany
  •   Switzerland
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/04/30
  •   128
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional 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)

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • DSM Nutritional Products, Inc.
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    • Deputy Head Institute for Clinical Chemistry and Hematology
    • Wolfgang Korte 
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    •   [---]*
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    •   [---]*
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    • Deputy Head Institute for Clinical Chemistry and Hematology
    • Wolfgang Korte 
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    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/05/01
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.