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

• ClinicalTrials.gov Identifier: NCT01354704
• Recruitment Status: Completed
• First Posted: May 17, 2011
• Last Update Posted: November 3, 2015
• Sponsor: Les Laboratoires des Médicaments Stériles
• Collaborator: Hopital Charles Nicolle
• Information provided by (Responsible Party): Les Laboratoires des Médicaments Stériles

Study Description

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 ®.

Condition or disease	Intervention/treatment	Phase
Deep Vein Thrombosis; Venous Thrombosis; Adverse Effect of Anticoagulants	Drug: Enoxaparin	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Echo-Doppler Assessment of the Occurrence of Asymptomatic Deep Vein Thrombosis (DVT) in Orthopedic Replacement Surgery Under Enoxaparine (PRENOXA)
• Study Start Date: March 2011
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Presence or absence of ultrasound findings in favor of asymptomatic DVT [ Time Frame: 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 :

1. To evaluate the efficacy and tolerability clinical Enox ® in these patients. [ Time Frame: 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Tunisia

Hospital Charle Nicolle

Tunis, Tunis BAB SOUIKA, Tunisia, 1006

Sponsors and Collaborators

Les Laboratoires des Médicaments Stériles

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

More Information

Publications of Results:

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.

• Responsible Party: Les Laboratoires des Médicaments Stériles
• ClinicalTrials.gov Identifier: NCT01354704
• Other Study ID Numbers: PRENOXA_2011
• First Posted: May 17, 2011
• Last Update Posted: November 3, 2015
• Last Verified: February 2012

Keywords provided by Les Laboratoires des Médicaments Stériles:

deep veinous thrombosis; enoxaparin

Additional relevant MeSH terms:

Thrombosis; Venous Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Enoxaparin; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action