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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01354704

Acronym

PRENOXA

Enrollment

153

Registered

2011-05-17

Start date

2011-03-31

Completion date

2015-10-31

Last updated

2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effect of Anticoagulants, Deep Vein Thrombosis, Venous Thrombosis

Keywords

deep veinous thrombosis, enoxaparin

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 ®.

Interventions

DRUGEnoxaparin

enoxaparin 4000 IU 1 injection/day in subcutaneous.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Presence or absence of ultrasound findings in favor of asymptomatic DVT	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

Measure	Time frame	Description
To evaluate the efficacy and tolerability clinical Enox ® in these patients.	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

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026