Echo-Doppler Assessment of the Occurrence of Asymptomatic DVT in Orthopedic Replacement Surgery Under Enoxaparin
NCT ID: NCT01354704
Last Updated: 2015-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
153 participants
INTERVENTIONAL
2011-03-31
2015-10-31
Brief Summary
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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 ®.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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lovenox
patient under lovenox 4000 IU
Enoxaparin
enoxaparin 4000 IU 1 injection/day in subcutaneous.
enoxa
patients under Enoxa 4000 IU
Enoxaparin
enoxaparin 4000 IU 1 injection/day in subcutaneous.
total knee replacement
patients undergoing total knee replacement
No interventions assigned to this group
total hip replacement
patient undergoing total knee replacement
No interventions assigned to this group
Interventions
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Enoxaparin
enoxaparin 4000 IU 1 injection/day in subcutaneous.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Hopital Charles Nicolle
OTHER
Les Laboratoires des Médicaments Stériles
INDUSTRY
Responsible Party
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Principal Investigators
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mondher kooli, MD
Role: STUDY_CHAIR
Hospital Charles Nicolle
Ramzi Bouzidi, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Charle Nicolle
Mustapha Azaiz, MD
Role: PRINCIPAL_INVESTIGATOR
Delta Medical Center
Abdelaziz Zarrouk, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Charles Nicollle
Locations
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Hospital Charle Nicolle
Tunis, Tunis BAB Souika, Tunisia
Countries
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References
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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.
Other Identifiers
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PRENOXA_2011
Identifier Type: -
Identifier Source: org_study_id
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