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

Les Laboratoires des Médicaments Stériles153 enrolled

Overview

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 ®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

153

Conditions

Deep Vein Thrombosis Venous Thrombosis Adverse Effect of Anticoagulants

Interventions

EnoxaparinDRUG

enoxaparin 4000 IU 1 injection/day in subcutaneous.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Charle Nicolle

Tunis, Tunis BAB Souika, Tunisia

Outcomes

Primary Outcomes

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.

Time frame: Day 7 and 35

Secondary Outcomes

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

Time frame: 3 months

Data from ClinicalTrials.gov

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