N/A
N=123
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
Thromboembolic Events
Bottom Line
View on ClinicalTrials.gov: NCT02052544 ↗Enrolled (actual)
123
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Overall Sensitivity and Specificity of Pefakit and Hemosil. — 83.3; 77; 81.5; 59.3 percentage of cases
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- dsm-firmenich Switzerland AG
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Sensitivity and Specificity of Pefakit and Hemosil. |
83.3; 77; 81.5; 59.3; 90.6; 94.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02052544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.