search
Back to results

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

Primary Purpose

Deep Vein Thrombosis, Venous Thrombosis, Adverse Effect of Anticoagulants

Status
Completed
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
Les Laboratoires des Médicaments Stériles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring deep veinous thrombosis, enoxaparin

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Charle Nicolle

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

No Intervention

No Intervention

Arm Label

lovenox

enoxa

total knee replacement

total hip replacement

Arm Description

patient under lovenox 4000 IU

patients under Enoxa 4000 IU

patients undergoing total knee replacement

patient undergoing total knee replacement

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
May 14, 2011
Last Updated
November 2, 2015
Sponsor
Les Laboratoires des Médicaments Stériles
Collaborators
Hopital Charles Nicolle
search

1. Study Identification

Unique Protocol Identification Number
NCT01354704
Brief Title
Echo-Doppler Assessment of the Occurrence of Asymptomatic DVT in Orthopedic Replacement Surgery Under Enoxaparin
Acronym
PRENOXA
Official Title
Echo-Doppler Assessment of the Occurrence of Asymptomatic Deep Vein Thrombosis (DVT) in Orthopedic Replacement Surgery Under Enoxaparine (PRENOXA)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Les Laboratoires des Médicaments Stériles
Collaborators
Hopital Charles Nicolle

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 ®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Venous Thrombosis, Adverse Effect of Anticoagulants
Keywords
deep veinous thrombosis, enoxaparin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lovenox
Arm Type
Active Comparator
Arm Description
patient under lovenox 4000 IU
Arm Title
enoxa
Arm Type
Active Comparator
Arm Description
patients under Enoxa 4000 IU
Arm Title
total knee replacement
Arm Type
No Intervention
Arm Description
patients undergoing total knee replacement
Arm Title
total hip replacement
Arm Type
No Intervention
Arm Description
patient undergoing total knee replacement
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
enoxaparin 4000 IU 1 injection/day in subcutaneous.
Primary Outcome Measure Information:
Title
Presence or absence of ultrasound findings in favor of asymptomatic DVT
Description
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.
Time Frame
Day 7 and 35
Secondary Outcome Measure Information:
Title
To evaluate the efficacy and tolerability clinical Enox ® in these patients.
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mondher kooli, MD
Organizational Affiliation
Hospital Charles Nicolle
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ramzi Bouzidi, MD
Organizational Affiliation
Hospital Charle Nicolle
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mustapha Azaiz, MD
Organizational Affiliation
Delta Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abdelaziz Zarrouk, MD
Organizational Affiliation
Hospital Charles Nicollle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Charle Nicolle
City
Tunis
State/Province
Tunis BAB SOUIKA
ZIP/Postal Code
1006
Country
Tunisia

12. IPD Sharing Statement

Citations:
Citation
1- Physiopathologie et prévention de la maladie thromboembolique veineuse postopératoire. Charles Marc Samama, Pierre Albaladejo. Sang Thrombose Vaisseaux 2008 ; 20, n°3 :138-43 2- Thromboses veineuses profondes. Dr Jean - Marc Schleich. Département de cardiologie et maladies vasculaires ; CHU de Rennes ; mis à jour le 6 septembre 1998 3- Prévention de la Thrombose veineuse. Dr H. Raybaud - MAJ 2006. Esculape.com : site de médecine générale. 4- Thrombose veineuse profonde. J. - L. Bosson, A. Franco. 1995 SIIM CHU de Grenoble 5- Suivi écho-doppler de thromboses veineuses profondes distales asymptomatique. M.-T BARRELLIER et col. Journal des maladies vasculaires. Masson, 2000, 25, 3 195-200. 6- 83ème Réunion annuelle de la société française de chirurgie orthopédique et traumatologique. Résumé des communications. Revue de chirurgie orthopédique et réparatrice de l'appareil moteur (2008) 94S, S231-S327.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs