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

Deep Vein Thrombosis Clinical Trial

— PRENOXA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354704
• Other study ID #: PRENOXA_2011
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2011
• Last updated: November 2, 2015
• Start date: March 2011
• Est. completion date: October 2015

Study information

• Verified date: February 2012
• Source: Les Laboratoires des Médicaments Stériles
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Office of Pharmacies and Medicines
• Study type: Interventional

Clinical Trial 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 ®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Effect of Anticoagulants
• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Enoxaparin
enoxaparin 4000 IU 1 injection/day in subcutaneous.

Locations

Country	Name	City	State
Tunisia	Hospital Charle Nicolle	Tunis	Tunis BAB SOUIKA

Sponsors (2)

Lead Sponsor	Collaborator
Les Laboratoires des Médicaments Stériles	Hospital Charles Nicolle Tunis.

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

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 ca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 7 and 35	Yes
Secondary	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	3 months	Yes