Trial | NCT01354704  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    enoxaparin ...

  • Study Participants

    153
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 ®.
Study Started
Mar 31
2011
Primary Completion
Jul 31
2015
Study Completion
Oct 31
2015
Last Update
Nov 03
2015
Estimate

Drug Enoxaparin

enoxaparin 4000 IU 1 injection/day in subcutaneous.

lovenox Active Comparator

patient under lovenox 4000 IU

enoxa Active Comparator

patients under Enoxa 4000 IU

total knee replacement No Intervention

patients undergoing total knee replacement

total hip replacement No Intervention

patient undergoing total knee replacement

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
No Results Posted