Echo-Doppler Assessment of the Occurrence of Asymptomatic DVT in Orthopedic Replacement Surgery Under Enoxaparin

Study Overview
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Brief Summary
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The objectives of the study are: o Objective ultrasound: Determine the presence or absence of subclinical DVT in practicing ultrasound-Doppler Day7 and Day35, patients who underwent TKA or THA o Clinical objective To evaluate the efficacy and tolerability clinical Enox ® in these patients compared with the original drug Lovenox ®.

Official Title
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Echo-Doppler Assessment of the Occurrence of Asymptomatic Deep Vein Thrombosis (DVT) in Orthopedic Replacement Surgery Under Enoxaparine (PRENOXA)

Conditions
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Deep Vein Thrombosis, Venous Thrombosis, Adverse Effect of Anticoagulants

Intervention / Treatment
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* Drug: Enoxaparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: man or woman aged over 18 years, admitted to undergo orthopedic total knee or total hip prosthesis requiring the use of enoxaparin 4000 IU for the Prophylaxis. Exclusion Criteria: Patient participating in another study. hypersensitivity to enoxaparin sodium, heparin unfractionated heparin or other low molecular weight. Patients at risk of major bleeding or uncontrolled including patients with recent stroke Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lovenox<br>patient under lovenox 4000 IU | Drug: Enoxaparin<br>* enoxaparin 4000 IU 1 injection/day in subcutaneous.<br>|
| Active Comparator: enoxa<br>patients under Enoxa 4000 IU | Drug: Enoxaparin<br>* enoxaparin 4000 IU 1 injection/day in subcutaneous.<br>|
| No Intervention: total knee replacement<br>patients undergoing total knee replacement | |
| No Intervention: total hip replacement<br>patient undergoing total knee replacement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of ultrasound findings in favor of asymptomatic DVT | After orthopedic surgery, patients are put under LMWH thromboprophylaxis based but some patients may be carrying an asymptomatic DVT. so we'll try the distal venous thrombosis rate in these patients using Doppler ultrasound. | Day 7 and 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy and tolerability clinical Enox ® in these patients. | Criteria for evaluating the effectiveness of Enox ®: Onset or without clinical signs of deep vein thrombosis in clinical postoperative Onset or without clinical signs of pulmonary embolism after surgery | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep veinous thrombosis, enoxaparin