Back to resultsHypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System) (TACT)
Primary Purpose
Venous Thrombosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional screening trial for Venous Thrombosis focused on measuring systemic lupus erythematosus, antiphospholipid syndrome, antiphospholipid antibodies
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Cases and Controls :
- Pregnancy
- Refusal of consent
- Difficulty of follow-up (not sufficient motivation)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Cases
Controls
Arm Description
Patients with SLE and/or APL and first vein thrombosis episode
age-matched; Patients with SLE and/or APL
Outcomes
Primary Outcome Measures
Thrombin potential measured with thrombinography
Measurement of IC50-APC (concentration of APC diminishing 50% thrombin potential at APC concentration = 0)
Secondary Outcome Measures
Full Information
NCT ID
NCT02892565
First Posted
September 2, 2016
Last Updated
September 8, 2016
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02892565
Brief Title
Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System)
Acronym
TACT
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis
Keywords
systemic lupus erythematosus, antiphospholipid syndrome, antiphospholipid antibodies
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cases
Arm Type
Experimental
Arm Description
Patients with SLE and/or APL and first vein thrombosis episode
Arm Title
Controls
Arm Type
Other
Arm Description
age-matched; Patients with SLE and/or APL
Intervention Type
Other
Intervention Name(s)
Blood sample
Primary Outcome Measure Information:
Title
Thrombin potential measured with thrombinography
Time Frame
baseline
Title
Measurement of IC50-APC (concentration of APC diminishing 50% thrombin potential at APC concentration = 0)
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Cases and Controls :
Pregnancy
Refusal of consent
Difficulty of follow-up (not sufficient motivation)
12. IPD Sharing Statement
Plan to Share IPD
No
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Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System)
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