Clinical trial NCT02052544: Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
Official title: Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboembolic Events
Keywords: determination of heparin levels
Patients
requiring
unfractionated
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 123
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Overall Sensitivity and Specificity of Pefakit and Hemosil.
timeFrame: within 2 - 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Wiesbaden
country: Germany
facility: Deutsche Klinik für Diagnostik
state: Hessen
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital -Institue for Clinical Chemistry and hematology
Study officials:
affiliation: Deputy Head Institute for Clinical Chemistry and Hematology
name: Wolfgang Korte
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsche Klinik für Diagnostik GmbH
name: Manuela K. Krause, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma Health Sciences Center- Department of Medicine
name: Rathbun Suman, MD
role: PRINCIPAL_INVESTIGATOR
References: