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

Completed

Conditions studied: Thromboembolic Events

In brief

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.

Key facts

Study ID

NCT02052544

Run by

dsm-firmenich Switzerland AG

People needed

123

Starts

2012-04-01

Expected to finish

2013-05-01

Last updated by the study team

2015-05-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Deutsche Klinik für Diagnostik — Wiesbaden, Hesse, Germany
• Cantonal Hospital -Institue for Clinical Chemistry and hematology — Sankt Gallen, Switzerland, Switzerland

Full record on ClinicalTrials.gov

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