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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Les Laboratoires des Médicaments Stériles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hospital Charles Nicolle Tunis.
Information provided by (Responsible Party):
Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov Identifier:
NCT01354704
First received: May 14, 2011
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

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 ®.


Condition Intervention Phase
Deep Vein Thrombosis
Enoxaparin
Anticoagulants
Drug: Enoxaparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Echo-Doppler Assessment of the Occurrence of Asymptomatic Deep Vein Thrombosis (DVT) in Orthopedic Replacement Surgery Under Enoxaparine (PRENOXA)

Resource links provided by NLM:


Further study details as provided by Les Laboratoires des Médicaments Stériles:

Primary Outcome Measures:
  • Presence or absence of ultrasound findings in favor of asymptomatic DVT [ Time Frame: Day 7 and 35 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • To evaluate the efficacy and tolerability clinical Enox ® in these patients. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 240
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lovenox
patient under lovenox 4000 IU
Drug: Enoxaparin
enoxaparin 4000 IU 1 injection/day in subcutaneous.
Active Comparator: enoxa
patients under Enoxa 4000 IU
Drug: Enoxaparin
enoxaparin 4000 IU 1 injection/day in subcutaneous.
No Intervention: total knee replacement
patients undergoing total knee replacement
No Intervention: total hip replacement
patient undergoing total knee replacement

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354704

Contacts
Contact: Abdelaziz zarrouk, Doctor 216 71 578 000 abdzarrouk@yahoo.fr

Locations
Tunisia
Hospital Charle Nicolle Recruiting
Tunis, Tunis BAB SOUIKA, Tunisia, 1006
Contact: Abdelaziz Zarrouk, MD    216 71 578 000    abdzarrouk@yahoo.fr   
Sponsors and Collaborators
Les Laboratoires des Médicaments Stériles
Hospital Charles Nicolle Tunis.
Investigators
Study Chair: mondher kooli, MD Hospital Charles Nicolle
Principal Investigator: Ramzi Bouzidi, MD Hospital Charle Nicolle
Principal Investigator: Mustapha Azaiz, MD Delta Medical Center
Principal Investigator: Abdelaziz Zarrouk, MD Hospital Charles Nicollle
  More Information

No publications provided

Responsible Party: Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov Identifier: NCT01354704     History of Changes
Other Study ID Numbers: PRENOXA_2011
Study First Received: May 14, 2011
Last Updated: February 16, 2012
Health Authority: Tunisia: Office of Pharmacies and Medicines

Keywords provided by Les Laboratoires des Médicaments Stériles:
deep veinous thrombosis
enoxaparin

Additional relevant MeSH terms:
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014