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

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

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 Overview

• Status: Completed
• Conditions: Venous Thrombosis; Deep Vein Thrombosis; Adverse Effect of Anticoagulants
• Intervention / Treatment: Drug: Enoxaparin

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tunisia
  • Tunis BAB SOUIKA
    • Tunis, Tunis BAB SOUIKA, Tunisia, 1006
      • Hospital Charle Nicolle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Les Laboratoires des Médicaments Stériles
• Collaborators: Hopital Charles Nicolle
• Investigators: Study Chair: mondher kooli, MD, Hospital Charles Nicolle; Principal Investigator: Ramzi Bouzidi, MD, Hospital Charle Nicolle; Principal Investigator: Mustapha Azaiz, MD, Delta Medical Center; Principal Investigator: Abdelaziz Zarrouk, MD, Hospital Charles Nicollle

Publications and helpful links

General Publications

• 1- Physiopathologie et prévention de la maladie thromboembolique veineuse postopératoire. Charles Marc Samama, Pierre Albaladejo. Sang Thrombose Vaisseaux 2008 ; 20, n°3 :138-43 2- Thromboses veineuses profondes. Dr Jean - Marc Schleich. Département de cardiologie et maladies vasculaires ; CHU de Rennes ; mis à jour le 6 septembre 1998 3- Prévention de la Thrombose veineuse. Dr H. Raybaud - MAJ 2006. Esculape.com : site de médecine générale. 4- Thrombose veineuse profonde. J. - L. Bosson, A. Franco. 1995 SIIM CHU de Grenoble 5- Suivi écho-doppler de thromboses veineuses profondes distales asymptomatique. M.-T BARRELLIER et col. Journal des maladies vasculaires. Masson, 2000, 25, 3 195-200. 6- 83ème Réunion annuelle de la société française de chirurgie orthopédique et traumatologique. Résumé des communications. Revue de chirurgie orthopédique et réparatrice de l'appareil moteur (2008) 94S, S231-S327.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 14, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (Estimate): May 17, 2011

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 2, 2015
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: enoxaparin; deep veinous thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin
• Other Study ID Numbers: PRENOXA_2011