Thromboembolic EventsNCT02052544
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
An observational study of Thromboembolic Events, run by dsm-firmenich Switzerland AG at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thromboembolic Events
- How many people
- 123 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2012to May 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Switzerland1 site
Cantonal Hospital -Institue for Clinical Chemistry and hematology
Sankt Gallen, Switzerland, CH-9007
About this study
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.
Read the 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.
- Conditions
- Thromboembolic Events
- Keywords
- determination of heparin levels, Patients, requiring, unfractionated
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study patients | Patients receiving unfractionated heparin (UFH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: within 2 - 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startApr 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thromboembolic EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Korte, Principal investigator, Deputy Head Institute for Clinical Chemistry and HematologyManuela K. Krause, MD, Principal investigator, Deutsche Klinik für Diagnostik GmbHRathbun Suman, MD, Principal investigator, University of Oklahoma Health Sciences Center- Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052544
- Sponsor's protocol ID
- PICT-01
- Status last verified
- May 2015
- First submitted
- 17 Jan 2014
- Last updated
- 6 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
- ClinicalTrials.gov ID
- NCT02052544
- Acronym / sponsor ID
- PICT-01
- Conditions
- Thromboembolic Events
- Keywords
- determination of heparin levels, Patients, requiring, unfractionated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Posted 6 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study patients | – | –Patients receiving unfractionated heparin (UFH) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Sensitivity and Specificity of Pefakit and Hemosil.
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Korte principal investigator
Deputy Head Institute for Clinical Chemistry and Hematology
Manuela K. Krause, MD principal investigator
Deutsche Klinik für Diagnostik GmbH
Rathbun Suman, MD principal investigator
University of Oklahoma Health Sciences Center- Department of Medicine
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolic Events, run by dsm-firmenich Switzerland AG at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Sensitivity and Specificity of Pefakit and Hemosil. (time frame: within 2 - 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.