Deep Vein ThrombosisPhase 4PRENOXANCT01354704
Echo-Doppler Assessment of the Occurrence of Asymptomatic DVT in Orthopedic Replacement Surgery Under Enoxaparin
A Phase 4 study testing Enoxaparin in people with Deep Vein Thrombosis and Venous Thrombosis, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Deep Vein Thrombosis, Venous Thrombosis, Adverse Effect of Anticoagulants
- What is being tested?
- Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteTunisia
- Study dates
- Mar 2011to Oct 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echo-Doppler Assessment of the Occurrence of Asymptomatic Deep Vein Thrombosis (DVT) in Orthopedic Replacement Surgery Under Enoxaparine (PRENOXA)
The objectives of the study are:
- Objective ultrasound: Determine the presence or absence of subclinical DVT in practicing ultrasound-Doppler Day7 and Day35, patients who underwent TKA or THA
- Clinical objective To evaluate the efficacy and tolerability clinical Enox ® in these patients compared with the original drug Lovenox ®.
- Being tested
- Enoxaparin
- Keywords
- deep veinous thrombosis, enoxaparin
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
enoxaparin 4000 IU 1 injection/day in subcutaneous.
| Study group | Role | What they receive |
|---|---|---|
| lovenox | Active comparator | patient under lovenox 4000 IU Receives: Drug: Enoxaparin |
| enoxa | Active comparator | patients under Enoxa 4000 IU Receives: Drug: Enoxaparin |
| total knee replacement | No intervention | patients undergoing total knee replacement |
| total hip replacement | No intervention | patient undergoing total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7 and 35
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hopital Charles Nicolle
- Responsible party
- Sponsor
- Investigators
- mondher kooli, MD, Study chair, Hospital Charles NicolleRamzi Bouzidi, MD, Principal investigator, Hospital Charle NicolleMustapha Azaiz, MD, Principal investigator, Delta Medical CenterAbdelaziz Zarrouk, MD, Principal investigator, Hospital Charles Nicollle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354704
- Sponsor's protocol ID
- PRENOXA_2011
- Acronym
- PRENOXA
- Status last verified
- Feb 2012
- First submitted
- 14 May 2011
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echo-Doppler Assessment of the Occurrence of Asymptomatic Deep Vein Thrombosis (DVT) in Orthopedic Replacement Surgery Under Enoxaparine (PRENOXA)
- ClinicalTrials.gov ID
- NCT01354704
- Acronym / sponsor ID
- PRENOXA / PRENOXA_2011
- Keywords
- deep veinous thrombosis, enoxaparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Les Laboratoires des Médicaments StérilesIndustry (pharma, biotech, devices)
- Collaborators
- Hopital Charles Nicolle
- Study start
- Mar 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the study are:
- Objective ultrasound: Determine the presence or absence of subclinical DVT in practicing ultrasound-Doppler Day7 and Day35, patients who underwent TKA or THA
- Clinical objective To evaluate the efficacy and tolerability clinical Enox ® in these patients compared with the original drug Lovenox ®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lovenox | Active comparator | Drug: Enoxaparinpatient under lovenox 4000 IU |
| enoxa | Active comparator | Drug: Enoxaparinpatients under Enoxa 4000 IU |
| total knee replacement | No intervention | –patients undergoing total knee replacement |
| total hip replacement | No intervention | –patient undergoing total knee replacement |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparinenoxaparin 4000 IU 1 injection/day in subcutaneous. | Drug | enoxa, lovenox |
Primary outcome
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.
1 secondary outcome
To evaluate the efficacy and tolerability clinical Enox ® in these patients.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Results publication1- 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.
Related trials for Deep Vein Thrombosis
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Active, not recruiting
This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Preventing Deep Vein Thrombosis (DVT) in Patients Undergoing On-pump Cardiac Surgery. The Study Will Include an Intervention Group That Receives the Nursing Protocol and a Control Group That Receives Routine
On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications, DVT - Deep Vein Thrombosis
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mondher kooli, MD study chair
Hospital Charles Nicolle
Ramzi Bouzidi, MD principal investigator
Hospital Charle Nicolle
Mustapha Azaiz, MD principal investigator
Delta Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin in people with Deep Vein Thrombosis and Venous Thrombosis, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of ultrasound findings in favor of asymptomatic DVT (time frame: Day 7 and 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01354704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.