Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-26 @ 12:35 AM
Study NCT ID:
NCT00362492
Status:
COMPLETED
Last Update Posted:
2010-10-28
First Post:
2006-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 850}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-27', 'studyFirstSubmitDate': '2006-08-09', 'studyFirstSubmitQcDate': '2006-08-09', 'lastUpdatePostDateStruct': {'date': '2010-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thromboembolism occuring between day 7-35 ;'}, {'measure': 'Major bleeding occuring between day 7-35 ;'}, {'measure': 'LMWH induced thrombopenia'}, {'measure': 'All cause mortality'}]}, 'conditionsModule': {'keywords': ['TKR', 'Ultrasonography', 'asymptomatic deep venous thrombosis', 'extended duration prophylaxis', 'short duration prophylaxis'], 'conditions': ['Thromboembolism', 'Arthroplasty Replacement, Knee']}, 'referencesModule': {'references': [{'pmid': '20797774', 'type': 'RESULT', 'citation': 'Barrellier MT, Lebel B, Parienti JJ, Mismetti P, Dutheil JJ, Vielpeau C; PROTHEGE study group; GETHCAM study group. Short versus extended thromboprophylaxis after total knee arthroplasty: a randomized comparison. Thromb Res. 2010 Oct;126(4):e298-304. doi: 10.1016/j.thromres.2010.07.018. Epub 2010 Aug 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '46 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First total knee joint replacement\n* Signed informed consent\n\nNon-inclusion Criteria:\n\n* History of venous thromboembolism/major bleeding/Heparin induced thrombopenia\n* Active cancer\n* Long-term anticoagulation'}, 'identificationModule': {'nctId': 'NCT00362492', 'briefTitle': 'Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': '9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PHRC-Prothege'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bilateral ultrasound examination 7+/- 2 after surgery', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '61014', 'city': 'Alençon', 'country': 'France', 'facility': 'Hospital Alençon', 'geoPoint': {'lat': 48.43476, 'lon': 0.09311}}, {'city': 'Angers', 'country': 'France', 'facility': 'Hospital University Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '76230', 'city': 'Bois-Guillaume', 'country': 'France', 'facility': 'Clinique du Cèdre', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Caen University hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '71100', 'city': 'Chalon-sur-Saône', 'country': 'France', 'facility': 'Clinique St Marie', 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'zip': '0941', 'city': 'Foix', 'country': 'France', 'facility': "Hospital Val D'ariège", 'geoPoint': {'lat': 42.96535, 'lon': 1.60705}}, {'zip': '85295', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Hospital La Roche sur Yon', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '78150', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Mignot Hospital', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '62800', 'city': 'Liévin', 'country': 'France', 'facility': 'Polyclinique de Riaumont', 'geoPoint': {'lat': 50.4198, 'lon': 2.78068}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hospital University Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Mayenne', 'country': 'France', 'facility': 'Hospital Nord Mayenne', 'geoPoint': {'lat': 48.30337, 'lon': -0.61383}}, {'zip': '03100', 'city': 'Montluçon', 'country': 'France', 'facility': 'Montluçon Hospital', 'geoPoint': {'lat': 46.34015, 'lon': 2.60254}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Poitiers University Hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Reims University Hospital', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'Clinique St André', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '59100', 'city': 'Roubaix', 'country': 'France', 'facility': 'Clinique St Jean', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'zip': '31077', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique St Jean Languedoc', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Marie-Thérèse Barrellier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Côte de Nacre University hospital'}, {'name': 'Claude Vielpeau, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Côte de Nacre University hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}}}}