Venous ThrombosisTACTNCT02892565
Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System)
A study testing Blood sample in people with Venous Thrombosis, run by Central Hospital, Nancy, France.
Trial summary
The purpose is to determine the hypercoagulable phenotype by thrombinography associated to an increased risk of symptomatic and objectively confirmed first venous thrombotic event. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases :
- Patients with SLE and/or APL and first documented deep vein thrombosis episode (minimum 6 months, maximum 6 years)
- Any weight and height
- Absence of current anticoagulant treatment but possibility of platelet function inhibitory treatment; actual guidelines suggest long-term anticoagulant treatment in patients with first episode of venous thrombosis and having APL; however, these patients can be studied if they are in one of these circumstances: 1/ "inconvenient" stop by patient, 2/ aspirin decided by doctor after prolonged treatment
- Controls:
- Patients with SLE and/or APL without thrombosis (venous or arterial)
- Any weight and height
- Possibility of platelet function inhibitory treatment (primary prophylaxis of arterial manifestations)
Who cannot join
- Cases and Controls :
- Pregnancy
- Refusal of consent
- Difficulty of follow-up (not sufficient motivation)
About this study
Official title: Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System): Marker of Venous Thrombosis Risk in Systemic Lupus and Antiphospholipid Syndrome? Case-control Study
The purpose is to determine the hypercoagulable phenotype by thrombinography associated to an increased risk of symptomatic and objectively confirmed first venous thrombotic event. This is a case-control study in a population with patients having systemic lupus erythematosus (SLE) and/or antiphospholipid antibodies (APL).
Secondary purposes are:
- To determine the frequency of hypercoagulable phenotype in study population;
- To analyze the sensibility: consequences of variation of hypercoagulable phenotype threshold on the importance of risk;
- To identify (genetic and not) factors for hypercoagulable phenotype and their frequency in different groups.
- Conditions
- Venous Thrombosis
- Being tested
- Blood sample
- Keywords
- systemic lupus erythematosus, antiphospholipid syndrome, antiphospholipid antibodies
- Medical subject headings
- Venous Thrombosis, Lupus Erythematosus, Systemic, Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | Patients with SLE and/or APL and first vein thrombosis episode Receives: Other: Blood sample |
| Controls | Other | age-matched; Patients with SLE and/or APL Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombin potential measured with thrombinography
Measured: baseline
Measurement of IC50-APC (concentration of APC diminishing 50% thrombin potential at APC concentration = 0)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startSep 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892565
- Sponsor's protocol ID
- PHRC 2005/TACT-LECOMPTE/NK
- Acronym
- TACT
- Status last verified
- Sep 2016
- First submitted
- 2 Sep 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System): Marker of Venous Thrombosis Risk in Systemic Lupus and Antiphospholipid Syndrome? Case-control Study
- ClinicalTrials.gov ID
- NCT02892565
- Acronym / sponsor ID
- TACT / PHRC 2005/TACT-LECOMPTE/NK
- Conditions
- Venous Thrombosis
- Keywords
- systemic lupus erythematosus, antiphospholipid syndrome, antiphospholipid antibodies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to determine the hypercoagulable phenotype by thrombinography associated to an increased risk of symptomatic and objectively confirmed first venous thrombotic event. This is a case-control study in a population with patients having systemic lupus erythematosus (SLE) and/or antiphospholipid antibodies (APL).
Secondary purposes are:
- To determine the frequency of hypercoagulable phenotype in study population;
- To analyze the sensibility: consequences of variation of hypercoagulable phenotype threshold on the importance of risk;
- To identify (genetic and not) factors for hypercoagulable phenotype and their frequency in different groups.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Other: Blood samplePatients with SLE and/or APL and first vein thrombosis episode |
| Controls | Other | Other: Blood sampleage-matched; Patients with SLE and/or APL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with SLE and/or APL and first documented deep vein thrombosis episode (minimum 6 months, maximum 6 years)
- Any weight and height
- Absence of current anticoagulant treatment but possibility of platelet function inhibitory treatment; actual guidelines suggest long-term anticoagulant treatment in patients with first episode of venous thrombosis and having APL; however, these patients can be studied if they are in one of these circumstances: 1/ "inconvenient" stop by patient, 2/ aspirin decided by doctor after prolonged treatment
- Patients with SLE and/or APL without thrombosis (venous or arterial)
- Any weight and height
Key exclusion criteria (4 listed)
- Pregnancy
- Refusal of consent
- Difficulty of follow-up (not sufficient motivation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample | Other | Cases, Controls |
Primary outcome
Thrombin potential measured with thrombinography
Time frame: baseline
Measurement of IC50-APC (concentration of APC diminishing 50% thrombin potential at APC concentration = 0)
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Venous Thrombosis, run by Central Hospital, Nancy, France.
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 8 inclusion and 4 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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Thrombin potential measured with thrombinography (time frame: baseline). The study lists 2 primary outcomes in all. 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 9 Sep 2016.