CompletedNot Applicable

Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System)

122 participantsStarted 2005-09

Plain-language 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: 1. To determine the frequency of hypercoagulable phenotype in study population; 2. To analyze the sensibility: consequences of variation of hypercoagulable phenotype threshold on the importance of risk; 3. To identify (genetic and not) factors for hypercoagulable phenotype and their frequency in different groups.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Thrombin potential measured with thrombinography

Timeframe: baseline

Measurement of IC50-APC (concentration of APC diminishing 50% thrombin potential at APC concentration = 0)

Timeframe: baseline

Trial details

NCT IDNCT02892565

SponsorCentral Hospital, Nancy, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-12

View on ClinicalTrials.gov More Venous Thrombosis trials