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

Les Laboratoires des Médicaments Stériles

Status and phase: Completed; Phase 4

Conditions: Adverse Effect of Anticoagulants; Deep Vein Thrombosis; Venous Thrombosis

Treatments: Drug: Enoxaparin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01354704

PRENOXA_2011

Details and patient eligibility

About

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 ®.

Enrollment: 153 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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153 participants in 4 patient groups

lovenox

Active Comparator group

Description:

patient under lovenox 4000 IU

Treatment:

Drug: Enoxaparin

enoxa

Active Comparator group

Description:

patients under Enoxa 4000 IU

Treatment:

Drug: Enoxaparin

total knee replacement

No Intervention group

Description:

patients undergoing total knee replacement

total hip replacement

No Intervention group

Description:

patient undergoing total knee replacement