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

NCT02052544 | Completed Results

• 1 other identifier: PICT-01
• Study Type: observational
• Target: 123
• Locations: 3 countries
• Sites: 3

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.

Conditions

Thromboembolic Events

Keywords

determination of heparin levels; Patients; requiring; unfractionated

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study patients

Patients receiving unfractionated heparin (UFH)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead

Study Sites (3)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Deutsche Klinik für Diagnostik

Wiesbaden, Hesse, 65191, Germany

Location

Cantonal Hospital -Institue for Clinical Chemistry and hematology

Sankt Gallen, Switzerland, CH-9007, Switzerland

Location

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Anne Brisset
• Organization: DSM Nutritional Products Ltd Branch Pentapharm

Anne.Brisset@pentapharm.com

41 61 706 4837

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: February 3, 2014
• Study Start: April 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 6, 2015
• Results First Posted: May 6, 2015

Record last verified: 2015-05

Locations

DE (1); US (1); CH (1)