Thromboembolic Events
Conditions
Keywords
determination of heparin levels, Patients, requiring, unfractionated
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.
Detailed 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.
Interventions
None listed
Sponsors
DSM Nutritional Products, Inc.
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Sensitivity and Specificity of Pefakit and Hemosil. | within 2 - 4 days | 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) |
Countries
Germany, Switzerland, United States
Participant flow
Recruitment details
FPI: Jul 2012; LPO May 2013 All three centers were hospitals (medical clinics) with certified laboratory.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Plasma Samples From Subjects Receiving Unfractionated Heparin 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. | 123 |
| Total | 123 |
Baseline characteristics
| Characteristic | Plasma Samples From Subjects Receiving Unfractionated Heparin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 67 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants |
| Age, Continuous | 65.5 years |
| Race/Ethnicity, Customized African American | 6 partecipants |
| Race/Ethnicity, Customized Caucasian | 114 partecipants |
| Race/Ethnicity, Customized Hispanic | 2 partecipants |
| Race/Ethnicity, Customized Oriental | 1 partecipants |
| Region of Enrollment Germany | 38 participants |
| Region of Enrollment Switzerland | 34 participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 123 |
| serious Total, serious adverse events | 0 / 123 |
Outcome results
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)
Time frame: within 2 - 4 days
Population: AVS (all valid subjects) population: All valid subjects with no major deviation affecting outcome.413 samples total analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pefakit | Overall Sensitivity and Specificity of Pefakit and Hemosil. | Overall Sensitivity% | 83.3 percentage of cases |
| Pefakit | Overall Sensitivity and Specificity of Pefakit and Hemosil. | Overall Specificity% | 81.5 percentage of cases |
| Pefakit | Overall Sensitivity and Specificity of Pefakit and Hemosil. | site #1 (St.Gallen) Sensitivity% | 90.6 percentage of cases |
| Pefakit | Overall Sensitivity and Specificity of Pefakit and Hemosil. | site #1 (St.Gallen) Specificity | 72.7 percentage of cases |
| Pefakit | Overall Sensitivity and Specificity of Pefakit and Hemosil. | site #2 (Wiesbaden) Sensitivity% | 74.4 percentage of cases |
| Pefakit | Overall Sensitivity and Specificity of Pefakit and Hemosil. | site #2 (Wiesbaden) Specificity% | 78.3 percentage of cases |
| Pefakit | Overall Sensitivity and Specificity of Pefakit and Hemosil. | site #3 (Oklahoma) Sensitivity% | 83.3 percentage of cases |
| Pefakit | Overall Sensitivity and Specificity of Pefakit and Hemosil. | site #3 (Oklahoma) Specificity% | 90 percentage of cases |
| Hemosil | Overall Sensitivity and Specificity of Pefakit and Hemosil. | site #3 (Oklahoma) Specificity% | 65 percentage of cases |
| Hemosil | Overall Sensitivity and Specificity of Pefakit and Hemosil. | Overall Sensitivity% | 77 percentage of cases |
| Hemosil | Overall Sensitivity and Specificity of Pefakit and Hemosil. | site #2 (Wiesbaden) Sensitivity% | 53.5 percentage of cases |
| Hemosil | Overall Sensitivity and Specificity of Pefakit and Hemosil. | Overall Specificity% | 59.3 percentage of cases |
| Hemosil | Overall Sensitivity and Specificity of Pefakit and Hemosil. | site #3 (Oklahoma) Sensitivity% | 80 percentage of cases |
| Hemosil | Overall Sensitivity and Specificity of Pefakit and Hemosil. | site #1 (St.Gallen) Sensitivity% | 94.3 percentage of cases |
| Hemosil | Overall Sensitivity and Specificity of Pefakit and Hemosil. | site #2 (Wiesbaden) Specificity% | 69.6 percentage of cases |
| Hemosil | Overall Sensitivity and Specificity of Pefakit and Hemosil. | site #1 (St.Gallen) Specificity | 27.3 percentage of cases |