Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-04-23 @ 7:23 PM
Study NCT ID:
NCT00161902
Status:
COMPLETED
Last Update Posted:
2006-10-23
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005271', 'term': 'Femur Head Necrosis'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2003-03'}, 'lastUpdateSubmitDate': '2006-10-20', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2006-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Arthroplasty', 'Hip Prosthesis', 'Cement Free Hip Prosthesis', 'Femur Head Necrosis', 'Coxarthrosis'], 'conditions': ['Hip Replacement Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to monitor the safety of FS VH S/D and evaluate whether FS VH S/D is superior to standard treatment in reducing blood loss in subjects undergoing total hip replacement with cement-free hip prostheses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\nEach subject to be included into the study must fulfill the following inclusion criteria:\n\n* Subjects receiving a cement free hip prosthesis due to coxarthrosis because of primary or dysplastic arthrosis grade 1 - 3 according to Crowe or rheumatoid arthritis as well as subjects receiving a cement free hip prosthesis due to femur head necrosis (Crowe classification).\n* ASA and NSAIDs have been discontinued one week prior to surgery\n* Written informed consent\n* Male and female at least 19 years of age\n\nExclusion Criteria:\n\nSubjects fulfilling the following exclusion criteria will not be recruited into the study:\n\n* Impaired coagulation\n* Previous hip surgery\n* Acetabular roof plastic\n* Known hypersensitivity to aprotinin or other components of the product\n* Immunodeficiency\n* Increased red cell production\n* Pregnant or lactating women (positive urine or serum pregnancy test; this test is required of any female subject who is not post menopausal or surgically sterilized).\n* Subjects concurrently participating in another clinical trial or having received another investigational drug within the last 30 days.\n\nAlso patients with abnormal coagulation values due to anticoagulants like coumadins or heparin must be excluded.'}, 'identificationModule': {'nctId': 'NCT00161902', 'briefTitle': 'Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Baxter Healthcare Corporation'}, 'officialTitle': 'A Randomized, Controlled, Multicenter Study to Evaluate Efficacy and Safety of Fibrin Sealant VH S/D for Hemostasis in Subjects Undergoing Total Hip Replacement', 'orgStudyIdInfo': {'id': '550001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fibrin Sealant Vapor-Heated Solvent/Detergent-treated', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Krems', 'state': 'Lower Austria', 'country': 'Austria', 'facility': 'A. ö. Krankenhaus Krems, Abteilung f. Orthopädie', 'geoPoint': {'lat': 48.40921, 'lon': 15.61415}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Allgemeines Krankenhaus der Stadt Wien, University Clinic for Orthopedics', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1220', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Donauspital im SMZ Ost, Department of Orthopedic Surgery', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '5664', 'city': 'Geldrop', 'country': 'Netherlands', 'facility': 'St. Anna Ziekenhuis, Orthopedic Surgery', 'geoPoint': {'lat': 51.42167, 'lon': 5.55972}}, {'zip': '6229', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Maastricht, Orthopedic Surgery', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '3078', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'St. Clara Ziekenhuis, Orthopedic Surgery', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Florian Gottsauner-Wolf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A. ö. Krankenhaus Krems, Austria'}, {'name': 'Axel Rüter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Unfall- und Wiederherstellungschirurgie des Zentralklinikums Augsburg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}}}}