Trial Outcomes & Findings for Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device (NCT NCT02052544)
NCT ID: NCT02052544
Last Updated: 2015-05-06
Results Overview
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)
COMPLETED
123 participants
within 2 - 4 days
2015-05-06
Participant Flow
FPI: Jul 2012; LPO May 2013 All three centers were hospitals (medical clinics) with certified laboratory.
Plasma from subjects treated with any other anticoagulants other than UFH. Plasma from subjects who have been undergoing fibrinolytic therapy within the previous 4 weeks.
Participant milestones
| Measure |
Study Patients
Patients receiving unfractionated heparin (UFH)
|
|---|---|
|
Overall Study
STARTED
|
123
|
|
Overall Study
COMPLETED
|
123
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
Baseline characteristics by cohort
| Measure |
Plasma Samples From Subjects Receiving Unfractionated Heparin
n=123 Participants
A total of 123 valid patients were recruited over three clinical centers (two in Europe, one in the US). The patients were selected from subjects receiving UFH therapy and who have given written informed consent. Excluded from the study were subjects treated with any other anticoagulants other than UFH, subjects who have been undergoing fibrinolytic therapy within the previous 4 weeks, subjects known to have a congenital bleeding disorder, subjects known to show coagulation factor deficiencies and subjects known to have a coagulation inhibitor or an unexplained APTT prolongation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
67 Participants
n=5 Participants
|
|
Age, Continuous
|
65.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
1 partecipants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 partecipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
114 partecipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 partecipants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 2 - 4 daysPopulation: AVS (all valid subjects) population: All valid subjects with no major deviation affecting outcome.413 samples total analyzed
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)
Outcome measures
| Measure |
Pefakit
n=121 Participants
Sensitivity and Specificity of Pefakit
|
Hemosil
n=121 Participants
Sensitivity and Specificity of Hemosil
|
|---|---|---|
|
Overall Sensitivity and Specificity of Pefakit and Hemosil.
Overall Sensitivity%
|
83.3 percentage of cases
Interval 75.7 to 89.4
|
77 percentage of cases
Interval 68.6 to 84.0
|
|
Overall Sensitivity and Specificity of Pefakit and Hemosil.
Overall Specificity%
|
81.5 percentage of cases
Interval 68.6 to 90.7
|
59.3 percentage of cases
Interval 45.0 to 72.4
|
|
Overall Sensitivity and Specificity of Pefakit and Hemosil.
site #1 (St.Gallen) Sensitivity%
|
90.6 percentage of cases
Interval 79.3 to 96.9
|
94.3 percentage of cases
Interval 84.3 to 98.8
|
|
Overall Sensitivity and Specificity of Pefakit and Hemosil.
site #1 (St.Gallen) Specificity
|
72.7 percentage of cases
Interval 39.0 to 94.0
|
27.3 percentage of cases
Interval 6.0 to 61.0
|
|
Overall Sensitivity and Specificity of Pefakit and Hemosil.
site #2 (Wiesbaden) Sensitivity%
|
74.4 percentage of cases
Interval 58.8 to 86.5
|
53.5 percentage of cases
Interval 37.7 to 68.8
|
|
Overall Sensitivity and Specificity of Pefakit and Hemosil.
site #2 (Wiesbaden) Specificity%
|
78.3 percentage of cases
Interval 56.3 to 92.5
|
69.6 percentage of cases
Interval 47.1 to 86.8
|
|
Overall Sensitivity and Specificity of Pefakit and Hemosil.
site #3 (Oklahoma) Sensitivity%
|
83.3 percentage of cases
Interval 65.3 to 94.4
|
80 percentage of cases
Interval 61.4 to 92.3
|
|
Overall Sensitivity and Specificity of Pefakit and Hemosil.
site #3 (Oklahoma) Specificity%
|
90 percentage of cases
Interval 68.3 to 98.8
|
65 percentage of cases
Interval 40.8 to 84.6
|
Adverse Events
Study Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anne Brisset
DSM Nutritional Products Ltd Branch Pentapharm
Results disclosure agreements
- Principal investigator is a sponsor employee Any proposed publication, lecture, manuscript, poster presentation or other disclosure or dissemination of the data or Results of this study by PI shall be submitted to DSM at least forty-five (45) days prior to its submission for publication or use for DSM's review, comment and approval. DSM reserves the right to have deleted from the proposed text all of DSM's Confidential Information which may be contained therein. DSM's comments shall be provided without undue delay.
- Publication restrictions are in place
Restriction type: OTHER