Variations in the Hemostatic System Induced by a Standardized Walking Test (NCT06418633) | Clinical Trial Compass
RecruitingNot Applicable
Variations in the Hemostatic System Induced by a Standardized Walking Test
France94 participantsStarted 2025-02-11
Plain-language summary
Two groups of patients will be compared: One group of patients with a history of venous thromboembolic disease and one group without. Both groups will be subjected to a walking test and with electrocardiogram measurements and blood tests.
Who can participate
Age range
18 Years – 65 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:
* Inclusion criteria common to both groups :
* Patients who have given written informed consent.
* Patients who are affiliated to or beneficiaries of a social security scheme.
Inclusion criteria specific to the Patient Group:
* Patients with a personal history of provoked venous thromboembolism, venous thrombosis and/or pulmonary embolism, with the last attack dating back to more than 6 months, and whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis.
Definition of provoked venous thromboembolism : The clinical criteria used to classify venous thromboembolism as provoked are :
* First year of combined oestrogen-progestogen oral contraception, or contraception using an oestrogen-impregnated vaginal ring or transcutaneous synthetic oestrogen patch.
* Hormonal stimulation for oocyte retrieval
* Pregnancy and 6 weeks post-partum
* Surgery
* Trauma
* Immobilisation in plaster or splint
* Outbreak of acute infectious disease
* Acute flare-up of inflammatory disease
* Prolonged air travel lasting at least 4 hours
* Prolonged strict bed rest lasting at least 3 consecutive days.
Inclusion criteria specific to the Control Group:
* Subjects with no personal history of venous thromboembolism
* Subjects with no family history of venous thromboembolism in first-degree relatives
* Subjects of the same sex and age with a tolerance of +/- 5 years in relation to the matched case.
Exclusion Criteria:
* Patients who are physically unable…
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
1
Thrombin generation dosage before effort in controls
Timeframe: Day 0
2
Thrombin generation dosage before effort in patients
Timeframe: Day 0
3
Thrombin generation dosage after effort in controls
Timeframe: Day 0
4
Thrombin generation dosage after effort in patients
Timeframe: Day 0
5
Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: controls
Timeframe: Day 7
6
Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: patients
Timeframe: Day 7
7
Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: controls