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
Recruitment status was Recruiting
Sponsor:
Les Laboratoires des Médicaments Stériles
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: October 31, 2014
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Venous Thrombosis 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: | March 2015 |
| Estimated Primary Completion Date: | February 2015 (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
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: | October 31, 2014 |
| Health Authority: | Tunisia: Office of Pharmacies and Medicines |
Keywords provided by Les Laboratoires des Médicaments Stériles:
|
deep veinous thrombosis enoxaparin |
Additional relevant MeSH terms:
|
Thrombosis Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases |
ClinicalTrials.gov processed this record on March 02, 2015