Skip to main content
OpenTrials
Completed

NCT Number: NCT01354704

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

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 ®.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Deep Vein Thrombosis Adverse Effect of Anticoagulants Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Charle Nicolle

Tunis, Tunis BAB Souika, 1006, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enoxaparin

Drug

enoxaparin 4000 IU 1 injection/day in subcutaneous.

Primary outcomes

  1. Presence or absence of ultrasound findings in favor of asymptomatic DVT

    Time frame: 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 outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Les Laboratoires des Médicaments Stériles

Industry

Collaborators

  • Hopital Charles Nicolle

Registry information

Official study title

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

Acronym: PRENOXA

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 17, 2011
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.