Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery … (NCT03634124) | Clinical Trial Compass
CompletedPhase 3
Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs
France146 participantsStarted 2019-02-21
Plain-language summary
The numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin, performed pre-surgically, could predict the risk of early venous thromboembolism after placement of total hip or knee prosthesis.
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:
* The patient must have his consent and signed the consent form.
* The patient must affiliated or a beneficiary of a health insurance plan.
* The patient is at least 18 years old
* Patient with an indication of total hip prosthesis or total knee replacement surgery set unilateral
Exclusion Criteria:
* The patient is participating in another interventional study.
* The patient is in an exclusion period determined by a previous study.
* Minor patients, people in emergency situations.
* The patient is under the protection of justice, guardianship or curatorship.
* The patient refuses to sign the consent.
* It is not possible to inform the patient.
* The patient is pregnant, parturient, or breastfeeding.
* The patient has a contraindication (or incompatible drug combination) to drug thromboprophylaxis applied according to good clinical practice and recommendations of learned societies
* Long-term anticoagulant therapy for personal thrombotic history.
* Known hemorrhagic disease.
* Haemorrhagic risk perceived during the consultation of preoperative anesthesia, leading to modify / develop the usual thromboprophylaxis.
* Chronic liver disease.
* Chronic renal failure with calculated clearance \<30 ml / min.
* Extreme body mass index: \<18 kg.m-2 or\> 40 kg.m-2
* total hip prosthesis or total knee prosthesis in the immediate aftermath of a bone fracture.
* total hip prosthesis resumption.
* Installation of more than one joint prosthesis.
* Surgery in the previo…
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
Estimate the numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin
Timeframe: Day 0
2
Occurrence of Symptomatic pulmonary embolism
Timeframe: Day 7 (± 2)
3
Occurrence of Symptomatic deep vein thrombosis somewhere in the body
Timeframe: Day 7 (± 2)
4
Occurrence of Symptomatic deep vein thrombosis in legs