Clinical trial NCT01354704: Echo-Doppler Assessment of the Occurrence of Asymptomatic DVT in Orthopedic Replacement Surgery Under Enoxaparin
Official title: Echo-Doppler Assessment of the Occurrence of Asymptomatic Deep Vein Thrombosis (DVT) in Orthopedic Replacement Surgery Under Enoxaparine (PRENOXA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Deep Vein Thrombosis
Venous Thrombosis
Adverse Effect of Anticoagulants
Keywords: deep veinous thrombosis
enoxaparin
Lead sponsor: Les Laboratoires des Médicaments Stériles
Sponsor class: INDUSTRY
Collaborators: name: Hopital Charles Nicolle
First posted: 2011-05-17
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 ®.


Eligibility 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

Primary outcomes:
measure: Presence or absence of ultrasound findings in favor of asymptomatic DVT
timeFrame: Day 7 and 35
Secondary outcomes:
measure: To evaluate the efficacy and tolerability clinical Enox ® in these patients.
timeFrame: 3 months
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Hospital Charle Nicolle
state: Tunis BAB SOUIKA
Study officials:
affiliation: Hospital Charles Nicolle
name: mondher kooli, MD
role: STUDY_CHAIR
affiliation: Hospital Charle Nicolle
name: Ramzi Bouzidi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Delta Medical Center
name: Mustapha Azaiz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Charles Nicollle
name: Abdelaziz Zarrouk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.