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

This study has been completed.

Sponsor:

Collaborator:

Hospital Charles Nicolle Tunis.

Information provided by (Responsible Party):

Les Laboratoires des Médicaments Stériles

ClinicalTrials.gov Identifier:

NCT01354704

First received: May 14, 2011

Last updated: November 2, 2015

Last verified: February 2012

History of Changes

Purpose

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	Intervention	Phase
Deep Vein Thrombosis Venous Thrombosis Adverse Effect of Anticoagulants	Drug: Enoxaparin	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (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)

Resource links provided by NLM:

MedlinePlus related topics: Blood Clots Deep Vein Thrombosis

U.S. FDA Resources

Further study details as provided by Les Laboratoires des Médicaments Stériles:

Primary Outcome Measures:

Presence or absence of ultrasound findings in favor of asymptomatic DVT [ Time Frame: Day 7 and 35 ] [ Designated as safety issue: Yes ]
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:

To evaluate the efficacy and tolerability clinical Enox ® in these patients. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
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


Enrollment:	153
Study Start Date:	March 2011
Study Completion Date:	October 2015
Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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.


Responsible Party:	Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov Identifier:	NCT01354704 History of Changes
Other Study ID Numbers:	PRENOXA_2011
Study First Received:	May 14, 2011
Last Updated:	November 2, 2015
Health Authority:	Tunisia: Office of Pharmacies and Medicines

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

ClinicalTrials.gov processed this record on September 30, 2016

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