Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-03-11 @ 6:55 AM
Study NCT ID:
NCT01354704
Status:
COMPLETED
Last Update Posted:
2015-11-03
First Post:
2011-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echo-Doppler Assessment of the Occurrence of Asymptomatic DVT in Orthopedic Replacement Surgery Under Enoxaparin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-02', 'studyFirstSubmitDate': '2011-05-14', 'studyFirstSubmitQcDate': '2011-05-16', 'lastUpdatePostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or absence of ultrasound findings in favor of asymptomatic DVT', 'timeFrame': 'Day 7 and 35', '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."}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy and tolerability clinical Enox ® in these patients.', 'timeFrame': '3 months', 'description': 'Criteria for evaluating the effectiveness of Enox ®:\n\n* Onset or without clinical signs of deep vein thrombosis in clinical postoperative\n* Onset or without clinical signs of pulmonary embolism after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['deep veinous thrombosis', 'enoxaparin'], 'conditions': ['Deep Vein Thrombosis', 'Venous Thrombosis', 'Adverse Effect of Anticoagulants']}, 'referencesModule': {'references': [{'type': 'RESULT', '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."}]}, 'descriptionModule': {'briefSummary': 'The objectives of the study are:\n\no Objective ultrasound: Determine the presence or absence of subclinical DVT in practicing ultrasound-Doppler Day7 and Day35, patients who underwent TKA or THA\n\no Clinical objective To evaluate the efficacy and tolerability clinical Enox ® in these patients compared with the original drug Lovenox ®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Patient participating in another study.\n* hypersensitivity to enoxaparin sodium, heparin unfractionated heparin or other low molecular weight.\n* Patients at risk of major bleeding or uncontrolled including patients with recent stroke\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT01354704', 'acronym': 'PRENOXA', 'briefTitle': 'Echo-Doppler Assessment of the Occurrence of Asymptomatic DVT in Orthopedic Replacement Surgery Under Enoxaparin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Les Laboratoires des Médicaments Stériles'}, 'officialTitle': 'Echo-Doppler Assessment of the Occurrence of Asymptomatic Deep Vein Thrombosis (DVT) in Orthopedic Replacement Surgery Under Enoxaparine (PRENOXA)', 'orgStudyIdInfo': {'id': 'PRENOXA_2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lovenox', 'description': 'patient under lovenox 4000 IU', 'interventionNames': ['Drug: Enoxaparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'enoxa', 'description': 'patients under Enoxa 4000 IU', 'interventionNames': ['Drug: Enoxaparin']}, {'type': 'NO_INTERVENTION', 'label': 'total knee replacement', 'description': 'patients undergoing total knee replacement'}, {'type': 'NO_INTERVENTION', 'label': 'total hip replacement', 'description': 'patient undergoing total knee replacement'}], 'interventions': [{'name': 'Enoxaparin', 'type': 'DRUG', 'description': 'enoxaparin 4000 IU 1 injection/day in subcutaneous.', 'armGroupLabels': ['enoxa', 'lovenox']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1006', 'city': 'Tunis', 'state': 'Tunis BAB Souika', 'country': 'Tunisia', 'facility': 'Hospital Charle Nicolle', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'mondher kooli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Charles Nicolle'}, {'name': 'Ramzi Bouzidi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Charle Nicolle'}, {'name': 'Mustapha Azaiz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Delta Medical Center'}, {'name': 'Abdelaziz Zarrouk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Charles Nicollle'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Les Laboratoires des Médicaments Stériles', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hopital Charles Nicolle', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}