NCT01354704

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 ®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 3, 2015

Status Verified

February 1, 2012

Enrollment Period

4.3 years

First QC Date

May 14, 2011

Last Update Submit

November 2, 2015

Conditions

Deep Vein ThrombosisVenous ThrombosisAdverse Effect of Anticoagulants

Keywords

deep veinous thrombosisenoxaparin

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of ultrasound findings in favor of asymptomatic DVT

    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.

    Day 7 and 35

Secondary Outcomes (1)

  • To evaluate the efficacy and tolerability clinical Enox ® in these patients.

    3 months

Study Arms (4)

lovenox

ACTIVE COMPARATOR

patient under lovenox 4000 IU

Drug: Enoxaparin

enoxa

ACTIVE COMPARATOR

patients under Enoxa 4000 IU

Drug: Enoxaparin

total knee replacement

NO INTERVENTION

patients undergoing total knee replacement

total hip replacement

NO INTERVENTION

patient undergoing total knee replacement

Interventions

EnoxaparinDRUG

enoxaparin 4000 IU 1 injection/day in subcutaneous.

enoxalovenox

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Charle Nicolle

Tunis, Tunis BAB Souika, 1006, Tunisia

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • mondher kooli, MD

    Hospital Charles Nicolle

    STUDY CHAIR

  • Ramzi Bouzidi, MD

    Hospital Charle Nicolle

    PRINCIPAL INVESTIGATOR

  • Mustapha Azaiz, MD

    Delta Medical Center

    PRINCIPAL INVESTIGATOR

  • Abdelaziz Zarrouk, MD

    Hospital Charles Nicollle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2011

First Posted

May 17, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

November 3, 2015

Record last verified: 2012-02

Locations

TU(1)