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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02052544
Recruitment Status : Completed
First Posted : February 3, 2014
Results First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.

Study Description
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Brief Summary:
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.

Condition or disease
Thromboembolic Events

Detailed 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.
Study Design
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Study Type : Observational
Actual Enrollment : 123 participants
Time Perspective: Prospective
Official Title: Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
Study Start Date : April 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013
Groups and Cohorts
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Group/Cohort
Study patients
Patients receiving unfractionated heparin (UFH)


Outcome Measures
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Primary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing UFH anticoagulation therapy will are needed for this study. Typically, such patients are undergoing cardiovascular surgery, are being treated for thromboembolic events, or are receiving heparin intravenously for thrombosis prophylaxis due to its more advantageous pharmacokinetic profile in some situations.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052544


Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma, Oklahoma, United States, 73104
Germany
Deutsche Klinik für Diagnostik
Wiesbaden, Hessen, Germany, 65191
Switzerland
Cantonal Hospital -Institue for Clinical Chemistry and hematology
St. Gallen, Switzerland, CH-9007
Sponsors and Collaborators
DSM Nutritional Products, Inc.
Investigators
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Principal Investigator: Wolfgang Korte Deputy Head Institute for Clinical Chemistry and Hematology
Principal Investigator: Manuela K. Krause, MD Deutsche Klinik für Diagnostik GmbH
Principal Investigator: Rathbun Suman, MD University of Oklahoma Health Sciences Center- Department of Medicine
More Information
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Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT02052544    
Other Study ID Numbers: PICT-01
First Posted: February 3, 2014    Key Record Dates
Results First Posted: May 6, 2015
Last Update Posted: May 6, 2015
Last Verified: May 2015
Keywords provided by DSM Nutritional Products, Inc.:
determination of heparin levels
Patients
requiring
unfractionated
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases