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

Phase 4

Completed

• Conditions: Adverse Effect of Anticoagulants; Deep Vein Thrombosis; Venous Thrombosis
• Interventions: Drug: Enoxaparin

• Registration Number: NCT01354704
• Lead Sponsor: Les Laboratoires des Médicaments Stériles

Brief Summary

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 ®.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-05-14
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Status Verified: 2012-02
• Primary Completion: 2015-07
• Study Completion: 2015-10
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
lovenox	Enoxaparin	patient under lovenox 4000 IU
enoxa	Enoxaparin	patients under Enoxa 4000 IU

Primary Outcome Measures

Name	Time	Method
Presence or absence of ultrasound findings in favor of asymptomatic DVT	Day 7 and 35	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy and tolerability clinical Enox ® in these patients.	3 months	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

Trial Locations

Locations (1)

Hospital Charle Nicolle; 🇹🇳 Tunis, Tunis BAB SOUIKA, Tunisia