Observational Prospectif Monocentric Registry of Patients Suffering From VIE (NCT02188056) | Clinical Trial Compass
CompletedNot Applicable
Observational Prospectif Monocentric Registry of Patients Suffering From VIE
France300 participantsStarted 2014-10-01
Plain-language summary
Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of these patients, risk factors have been identified (congenital or acquired thrombophilia, cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the etiology remains unknown, justifying the need for well-conducted studies to determine other potential risk factors. In addition, the expansion of treatment options with the arrival on the market of new direct oral anticoagulants, allows comparative studies on the effectiveness and frequency of adverse events for each treatment.
Who can participate
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:
* diagnosis of venous thromboembolism established by a validated test (venous Doppler ultrasound of the lower limbs, pulmonary angiography, lung scan ventilation / perfusion),
* diagnosis of venous thromboembolism made within 15 days,
* the previous inclusion in the register (outpatient or inpatient)
Exclusion Criteria:
* person doesn't wish to participate in this study
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.