Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs

Study Overview
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Brief Summary
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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.

Official Title
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Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs

Conditions
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Total Hip Prosthesis, Knee Prosthesis, Deep Vein Thrombosis

Intervention / Treatment
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* Biological: Blood test
* Other: Doppler ultrasound


Participation Criteria
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Eligibility Criteria
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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 previous 3 months. Infective push in the previous 3 months. Indication of haemostatic treatment for abnormal haemorrhagic risk. Severe impairment of renal function with a calculated clearance <30 ml / min. Contraindication (allergic, metabolic, other ...) to usual drug thromboprophylaxis. Condition requiring dosage adjustment of drug thromboprophylaxis. Indication to put in place intermittent pneumatic compression for perioperative thromboprophylaxis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional group<br> | Biological: Blood test<br>* Additional blood test of 4,5 ml of venous blood<br>Other: Doppler ultrasound<br>* Vascular ultrasonic vascular exploration of the lower limbs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Numerical value | Day 0 | 
| Occurrence of Symptomatic pulmonary embolism | yes/non | Day 7 (± 2) | 
| Occurrence of Symptomatic deep vein thrombosis somewhere in the body | Yes/no | Day 7 (± 2) | 
| Occurrence of Symptomatic deep vein thrombosis in legs | Yes/non | Day 7 (± 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of proximal Symptomatic deep vein thrombosis in legs | Yes/no | Day 7 (± 2) | 
| Occurrence of distal Symptomatic deep vein thrombosis in legs | Yes/no | Day 7 (± 2) | 
| Occurrence of muscular Symptomatic deep vein thrombosis in legs | Yes/no | Day 7 (± 2) | 
| Occurrence of any kind of Symptomatic deep vein thrombosis in legs except muscular | Yes/no | Day 7 (± 2) | 
| Occurrence of proximal asymptomatic deep vein thrombosis in legs by doppler ultrasound | Yes/no | Day 7 (± 2) | 
| Occurrence of distal asymptomatic deep vein thrombosis in legs by doppler ultrasound | Yes/no | Day 7 (± 2) | 
| Occurrence of muscular asymptomatic deep vein thrombosis in legs by doppler ultrasound | Yes/no | Day 7 (± 2) | 
| Occurrence of any kind of asymptomatic deep vein thrombosis except muscular in legs by doppler ultrasound | Yes/no | Day 7 (± 2) |