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

Thromboembolic Events Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052544
• Other study ID #: PICT-01
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: May 4, 2015
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2015
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Thromboembolic Events
• Thromboembolism

Locations

Country	Name	City	State
Germany	Deutsche Klinik für Diagnostik	Wiesbaden	Hessen
Switzerland	Cantonal Hospital -Institue for Clinical Chemistry and hematology	St. Gallen
United States	University of Oklahoma Health Sciences Center	Oklahoma	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Sensitivity and Specificity of Pefakit and Hemosil.	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)	within 2 - 4 days	No