[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560808":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":47,"centralContacts":51,"locations":60,"responsibleParty":162,"collaborators":36,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":167,"sex":173,"minAge":174,"maxAge":36,"enrollmentInfo":175,"targetDuration":36,"studyType":178,"phases":179,"briefSummary":181,"conditions":182,"keywords":187,"overallStatus":63,"whyStopped":36,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",[8,14,19,23,28],{"label":9,"type":10,"description":11,"interventionNames":12},"DISTINCT 1 short duration prophylaxis","EXPERIMENTAL","Patients with a low VTE risk (predicted 3-months postoperative VTE risk \\\u003C1%) based on the TRiP(plasty) score. (Nemeth, 2024)",[13],"Other: Short duration prophylaxis",{"label":15,"type":16,"description":11,"interventionNames":17},"DISTINCT 1 control","ACTIVE_COMPARATOR",[18],"Other: Control",{"label":20,"type":6,"description":21,"interventionNames":22},"DISTINCT 2 observational arm","Patients with an intermediate VTE risk (predicted 3-months postoperative VTE risk ≥1%-≤1.5%) based on the TRiP(plasty) score. (Nemeth, 2024)",[18],{"label":24,"type":10,"description":25,"interventionNames":26},"DISTINCT 3 extended prophylaxis","Patients with a high VTE risk (predicted 3-months postoperative VTE risk \\>1.5%) based on the TRiP(plasty) score. (Nemeth, 2024)",[27],"Other: Higher intensity and longer duration prophylaxis",{"label":29,"type":16,"description":25,"interventionNames":30},"DISTINCT 3 control",[18],[32,37,41],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Short duration prophylaxis","Only during hospitalization: any type of LMWH or DOAC in a prophylactic dose as approved by the Dutch guideline \"Antitrombotisch beleid\". First dose of LMWH within 6-24h following surgery. First dose of apixaban within 12-24h following surgery. First dose of rivaroxaban 6-10h following surgery. First dose of dabigatran within 1-4h following surgery. The applied type of anticoagulant is according to the local standard use (same type as used for control group).",[9],null,{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Higher intensity and longer duration prophylaxis","The use of any thrombocyte aggregation inhibitors should be discontinued 5 days prior to surgery. Day 0-2: any type of LMWH or DOAC in a prophylactic dose as approved by the Dutch guidelines. First dose of LMWH within 6-24h following surgery. First dose of apixaban within 12-24h following surgery. First dose of rivaroxaban 6-10h following surgery. First dose of dabigatran within 1-4h following surgery. The applied type of anticoagulant is according to the local standard use.\n\nDay 3: Apixaban 5mg b.i.d., continued until 6 weeks after surgery, conditional on the fact that no active bleeding of the surgical wound can be observed. In case of active bleeding, the prophylactic dose of thrombosis prophylaxis is continued. Thereafter, in case no active bleeding has been observed for 24 hours, the 5mg b.i.d. apixaban treatment will be started.\n\nThe 5mg b.i.d. apixaban dose will be adjusted to 2.5mg b.i.d. in case of an impaired kidney function (defined as eGFR 10-30ml\u002Fmin).",[24],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Control","4 weeks: any type of LMWH or DOAC in a prophylactic dose as approved by the Dutch guidelines. First dose of LMWH within 6-24h following surgery. First dose of apixaban within 12-24h following surgery. First dose of rivaroxaban 6-10h following surgery. First dose of dabigatran within 1-4h following surgery. The applied type of anticoagulant is according to the local standard use.",[15,20,29],[46],"Standard treatment",[48],{"name":49,"affiliation":5,"role":50},"Banne Nemeth, dr","PRINCIPAL_INVESTIGATOR",[52,56],{"name":49,"role":53,"phone":54,"phoneExt":36,"email":55},"CONTACT","+31715264037","B.Nemeth@lumc.nl",{"name":57,"role":53,"phone":58,"phoneExt":36,"email":59},"Ruben Y Kok, drs","+31715265633","R.Y.Kok@lumc.nl",[61,75,85,95,105,114,124,133,143,153],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":36},"Gelre Ziekenhuizen","RECRUITING","Apeldoorn","Gelderland","7334 DZ","Netherlands","NL",{"type":70,"coordinates":71},"Point",[72,73],5.96944,52.21,{"lat":73,"lon":72},{"facility":76,"status":63,"city":77,"state":78,"zip":79,"country":67,"countryCode":68,"cosmosGeoPoint":80,"geoPoint":84,"contacts":36},"Zuyderland","Geleen","Limburg","6162 BG",{"type":70,"coordinates":81},[82,83],5.82917,50.97417,{"lat":83,"lon":82},{"facility":86,"status":63,"city":87,"state":88,"zip":89,"country":67,"countryCode":68,"cosmosGeoPoint":90,"geoPoint":94,"contacts":36},"Anna Ziekenhuis","Geldrop","North Brabant","5564EH",{"type":70,"coordinates":91},[92,93],5.55972,51.42167,{"lat":93,"lon":92},{"facility":96,"status":97,"city":98,"state":88,"zip":99,"country":67,"countryCode":68,"cosmosGeoPoint":100,"geoPoint":104,"contacts":36},"Bravis ziekenhuis","NOT_YET_RECRUITING","Roosendaal","4708 AE",{"type":70,"coordinates":101},[102,103],4.46528,51.53083,{"lat":103,"lon":102},{"facility":106,"status":63,"city":107,"state":88,"zip":108,"country":67,"countryCode":68,"cosmosGeoPoint":109,"geoPoint":113,"contacts":36},"Elisabeth-TweeSteden Ziekenhuis","Tilburg","5022GC",{"type":70,"coordinates":110},[111,112],5.0913,51.55551,{"lat":112,"lon":111},{"facility":115,"status":63,"city":116,"state":117,"zip":118,"country":67,"countryCode":68,"cosmosGeoPoint":119,"geoPoint":123,"contacts":36},"OLVG","Amsterdam","North Holland","1091AC",{"type":70,"coordinates":120},[121,122],4.88969,52.37403,{"lat":122,"lon":121},{"facility":125,"status":63,"city":126,"state":117,"zip":127,"country":67,"countryCode":68,"cosmosGeoPoint":128,"geoPoint":132,"contacts":36},"Bergman Clinics","Naarden","1411DE",{"type":70,"coordinates":129},[130,131],5.1625,52.29583,{"lat":131,"lon":130},{"facility":134,"status":63,"city":135,"state":136,"zip":137,"country":67,"countryCode":68,"cosmosGeoPoint":138,"geoPoint":142,"contacts":36},"Isala ziekenhuis","Zwolle","Overijssel","8025AB",{"type":70,"coordinates":139},[140,141],6.09444,52.5125,{"lat":141,"lon":140},{"facility":144,"status":63,"city":145,"state":146,"zip":147,"country":67,"countryCode":68,"cosmosGeoPoint":148,"geoPoint":152,"contacts":36},"Alrijne","Leiderdorp","South Holland","2353 GA",{"type":70,"coordinates":149},[150,151],4.52917,52.15833,{"lat":151,"lon":150},{"facility":154,"status":63,"city":155,"state":146,"zip":156,"country":67,"countryCode":68,"cosmosGeoPoint":157,"geoPoint":161,"contacts":36},"Reinier Haga Orthopedisch Centrum","Zoetermeer","2725NA",{"type":70,"coordinates":158},[159,160],4.49306,52.0575,{"lat":160,"lon":159},{"type":50,"investigatorFullName":163,"investigatorTitle":164,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"B.Nemeth","Postdoctoral researcher Clinical epidemiology","100560808","phase-4-individual-targeted-thrombosis-prophylaxis-versus-the-standard-one-size-fits-all-approach-in-patients-undergoing-total-hip-or-total-knee-replacement-100560808",false,"NCT06581965","inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT","The DISTINCT Trial: inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT: a National, Multicenter, Randomized, Multi-arm, Open-label Trial.","DISTINCT","Inclusion Criteria:\n\n* Scheduled to undergo an elective total hip arthroplasty or total knee arthroplasty\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Primary arthroplasty for fractures\n* Revision surgery\n* Hemiarthroplasty\n* Pregnancy\n* Current use of therapeutic anticoagulant therapy of any type (e.g., LMWH, DOAC, vitamin K antagonist)\n* A contraindication for either study drug\n* Insufficient knowledge of the Dutch language\n* Insufficient mental or physical ability to fulfil trial requirements\n* Active malignancy (i.e. cancer diagnosis within six months before surgery (excluding basal-cell or squamous-cell carcinoma of the skin), recently recurrent or progressive cancer or any cancer that required anti-cancer treatment within six months before surgery)\n* Patients using thrombocyte aggregation inhibitors that cannot be temporarily discontinued at the discretion of their treating physician","ALL","18 Years",{"count":176,"type":177},10078,"ESTIMATED","INTERVENTIONAL",[180],"PHASE4","After hip or knee replacement all patients receive a standardized treatment with blood thinners, this medication is called thrombosis prophylaxis. However, despite this standard treatment some individuals still develop venous thrombosis (VTE), while others experience bleeding. This indicates that not all patients have the same VTE risk following surgery. Individualizing the amount of thrombosis prophylaxis following surgery might lead to less thrombotic and bleeding events. In this study the investigators individualize the treatment with thrombosis prophylaxis based on the medical history of a patient.\n\nThe main questions this study aims to answer are:\n\nCan thrombosis prophylaxis be shortened in patients with a low VTE risk to decrease the risk of bleeding without increasing the risk of VTE? Does an increase in the dose and duration of thrombosis prophylaxis in patients with a high VTE risk reduce the risk of VTE without inducing an unacceptable risk of bleeds?\n\nResearchers will compare both the shortened treatment in low VTE risk patients and the intensified and extended treatment in high VTE risk patients with the standard treatment to assess the risk of VTE and bleeding in comparison to the standard treatment.\n\nParticipants will receive 4 questionnaires to evaluate whether they have experienced a VTE or bleed. For this study no additional hospital visits are necessary.",[183,184,185,186],"Venous Thromboembolism","Venous Thromboses","Pulmonary Embolism","Deep Vein Thrombosis",[188,189,190,191,192,193],"Venous thromboembolism","Prophylaxis","Individualized Medicine","Total hip arthroplasty","Total knee arthroplasty","Randomized controlled trial","2025-08-26",{"date":196,"type":197},"2025-09-03","ACTUAL",{"date":199,"type":197},"2024-11-11",{"date":201,"type":177},"2031-02-01",{"name":5,"class":6},10]