Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-02 @ 12:10 AM
Study NCT ID:
NCT01891461
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2013-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C411004', 'term': 'FloSeal Matrix'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2013-06-25', 'studyFirstSubmitQcDate': '2013-06-28', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need of transfusion post-op (yes/no, how many)', 'timeFrame': 'post op day 1 to 7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'post-operative bleeding', 'floseal'], 'conditions': ['Intraoperative Bleeding', 'Post-operative Bleeding']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare Floseal to our standard of care (SOC) to decrease intraoperative and immediate post-operative bleeding.', 'detailedDescription': 'A prospective randomized single-blind clinical trial will be conducted at the Hôpital du Sacré-Coeur de Montréal and Hôpital Jean-Talon. All patients admitted for total knee arthroplasty (TKA) between January 2012 and September 2013 Outcome variable: Patient receiving Floseal or SOC\n\nVariables under study:\n\nPrimary end point:\n\nNeed of transfusion post-op (yes/no, how many)\n\nPatient will be transfused if :\n\nHg \\< 80 g/L plus if patient is symptomatic: orthostatic hypotension, tachycardia (pulse\\> 100/min, hypotension (\\< 90/60), hx : CVA, CAD)\n\nSecondary end point:\n\n1. Efficacy (during hospital stay)\n\n * Pre-op and post-op Hg (\\> 100; 80-100; \\<80)\n * Hemovac blood drainage (ml)\n * Per operative bleeding (ml)\n2. Safety (Follow up: 6wks, 6 ms, 12 ms, 24 ms)\n\n * Post-op complications: infection, pain, oedema, allergic reaction.\n * Functional outcomes: Knee Society Score (KSS), Western Ontario and McMaster Universities questionnaire (WOMAC), International knee documentation committee form (IKDC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects above 18 years old admitted for a TKA between January 2012 and September 2013at Hôpital du Sacré-Coeur de Montréal (HSCM) and Hôpital Jean-Talon (HJT), Montréal, Quebec, Canada.\n\n * TKA done without the use of a tourniquet except while cementing only (±10 minutes)\n * TKA done with Smith and Nephew "Genesis II" or Zimmer "NexGen" total knee replacement implants\n\nExclusion Criteria:\n\n* • Prior osteotomy or knee surgery within last 6-8 wks\n\n * Active, local infection or systemic infection\n * Participation in any other pharmaceutical or clinical investigation\n * Bleeding disorders (Hemophilia A, Hemophilia B, Von Willebrand disease, factor VIII deficiency, Vitamin K deficiency, Thrombocytopenia (platelets \\< 50 x 109 per litre)\n * Patients with known allergies to materials of bovine origin'}, 'identificationModule': {'nctId': 'NCT01891461', 'briefTitle': 'Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR', 'organization': {'class': 'OTHER', 'fullName': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal"}, 'officialTitle': 'A Prospective, Randomized Study to Compare the Addition of Granules of Gelatine + Thrombin to Our Standard of Care (SOC) to Control Post Operative Bleeding in Total Knee Replacement', 'orgStudyIdInfo': {'id': 'BS12-000835'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Floseal', 'description': 'Floseal will be administered during the procedure and prior to release of the tourniquet (if used PRN during the cementing procedure (±10 minutes)) and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissue by the use of a delivery syringe. Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.\n\nPreparation of Floseal requires mixing 5,000 US units of package thrombin (bovine-derived) made up to 5 milliliters of saline solution, to the Gelatin Matrix solution. In this study, 2-4 vials (15-20 mls total) will be used.', 'interventionNames': ['Drug: Floseal']}, {'type': 'NO_INTERVENTION', 'label': 'standard of care', 'description': 'For patients randomized to the control arm, the surgery will proceed in an otherwise identical fashion (with release of the tourniquet if used PRN during cementing procedure (±10 minutes)) and hemostasis followed by drain insertion and wound closure.'}], 'interventions': [{'name': 'Floseal', 'type': 'DRUG', 'otherNames': ['Hemostatic Matrix'], 'description': 'Floseal (5 milliliters) will be applied to the exposed bone in the following order: around the margins of the tibia, the femur (anterior surface, intercondylar notch, exposed medial and lateral condyles) and around the un resurfaced portion of the patella. The other syringes (each of 5 milliliters) will then be applied to the supra-patellar synovium and into the medial and lateral gutters of the knee. No Floseal will be applied outside the knee joint capsule.', 'armGroupLabels': ['Floseal']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital du sacre coeur de montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Julio C Fernandes, MDMScMBAPhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal", 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc, MBA, PhD', 'investigatorFullName': 'Dr Julio Fernandes', 'investigatorAffiliation': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal"}}}}