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

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

Study Description
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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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354704


Locations
Tunisia
Hospital Charle Nicolle
Tunis, Tunis BAB SOUIKA, Tunisia, 1006
Sponsors and Collaborators
Les Laboratoires des Médicaments Stériles
Hospital Charles Nicolle Tunis.
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
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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     History of Changes
Other Study ID Numbers: PRENOXA_2011
First Posted: May 17, 2011    Key Record Dates
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