Echo-Doppler Assessment of the Occurrence of Asymptomatic DVT in Orthopedic Replacement Surgery Under Enoxaparin (PRENOXA)
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ClinicalTrials.gov Identifier: NCT01354704 |
Recruitment Status :
Completed
First Posted : May 17, 2011
Last Update Posted : November 3, 2015
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Deep Vein Thrombosis Venous Thrombosis Adverse Effect of Anticoagulants | Drug: Enoxaparin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 153 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (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) |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | October 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: lovenox
patient under lovenox 4000 IU
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Drug: Enoxaparin
enoxaparin 4000 IU 1 injection/day in subcutaneous. |
Active Comparator: enoxa
patients under Enoxa 4000 IU
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Drug: Enoxaparin
enoxaparin 4000 IU 1 injection/day in subcutaneous. |
No Intervention: total knee replacement
patients undergoing total knee replacement
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No Intervention: total hip replacement
patient undergoing total knee replacement
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- 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.
- 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

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354704
Tunisia | |
Hospital Charle Nicolle | |
Tunis, Tunis BAB SOUIKA, Tunisia, 1006 |
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 |
Responsible Party: | Les Laboratoires des Médicaments Stériles |
ClinicalTrials.gov Identifier: | NCT01354704 |
Other Study ID Numbers: |
PRENOXA_2011 |
First Posted: | May 17, 2011 Key Record Dates |
Last Update Posted: | November 3, 2015 |
Last Verified: | February 2012 |
deep veinous thrombosis enoxaparin |
Thrombosis Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Enoxaparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |