[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569579":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":54,"locations":62,"responsibleParty":190,"collaborators":194,"id":201,"slug":202,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":203,"sex":209,"minAge":210,"maxAge":26,"enrollmentInfo":211,"targetDuration":26,"studyType":214,"phases":215,"briefSummary":217,"conditions":218,"keywords":221,"overallStatus":142,"whyStopped":26,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},{"fullName":5,"class":6},"Helsinki University Central Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early resumption","EXPERIMENTAL","Oral anticoagulation therapy is resumed on the 5th postoperative day following burr-hole surgery for chronic subdural hematoma.",[13],"Drug: Early Resumption of Oral Anticoagulation Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Late resumption","ACTIVE_COMPARATOR","Oral anticoagulation therapy is resumed on the 30th postoperative day following burr-hole surgery for chronic subdural hematoma.",[19],"Drug: Late Resumption of Oral Anticoagulation Therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Early Resumption of Oral Anticoagulation Therapy","The patient's prescribed anticoagulant therapy for atrial fibrillation is resumed on the 5th postoperative day following burr-hole surgery for chronic subdural hematoma. This early resumption strategy is compared to the standard practice of resuming anticoagulation therapy on the 30th postoperative day.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Late Resumption of Oral Anticoagulation Therapy","The patient's prescribed anticoagulant therapy for atrial fibrillation is resumed on the 30th postoperative day following burr-hole surgery for chronic subdural hematoma. This standard resumption strategy is compared to the early approach of resuming anticoagulation therapy on the 5th postoperative day.",[15],[32,36,39,42,45,48,51],{"name":33,"affiliation":34,"role":35},"Rahul Raj, MD, PhD","Helsinki University Hospital & University of Helsinki","STUDY_CHAIR",{"name":37,"affiliation":34,"role":38},"Jarno Satopää, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":38},"Jussi P Posti, MD, PhD","Turku University Hospital and University of Turku",{"name":43,"affiliation":44,"role":38},"Teemu Luoto, MD, PhD","Tampere University Hospital and Tampere University",{"name":46,"affiliation":47,"role":38},"Nils Danner, MD, PhD","Kuopio University Hospital and University of Eastern Finland",{"name":49,"affiliation":50,"role":38},"Oula Knuutinen, MD, PhD","Oulu University Hospital and University of Oulu",{"name":52,"affiliation":53,"role":38},"Jiri Bartek, MD, PhD","Karolinska University Hospital",[55,59],{"name":33,"role":56,"phone":57,"phoneExt":26,"email":58},"CONTACT","+358504272516","rahul.raj@hus.fi",{"name":37,"role":56,"phone":60,"phoneExt":26,"email":61},"+358504286743‬","jarno.satopaa@hus.fi",[63,87,106,123,140,170],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Oulu University Hospital","NOT_YET_RECRUITING","Oulu","North Ostrobothnia","90220","Finland","FI",{"type":72,"coordinates":73},"Point",[74,75],25.46816,65.01236,{"lat":75,"lon":74},[78,81,82,85],{"name":49,"role":56,"phone":79,"phoneExt":26,"email":80},"‭+358405842879‬","oula.knuutinen@oulu.fi",{"name":49,"role":38,"phone":26,"phoneExt":26,"email":26},{"name":83,"role":84,"phone":26,"phoneExt":26,"email":26},"Tommi Korhonen, MD, PhD","SUB_INVESTIGATOR",{"name":86,"role":84,"phone":26,"phoneExt":26,"email":26},"Sami Tetri, MD, PhD",{"facility":88,"status":65,"city":89,"state":90,"zip":91,"country":69,"countryCode":70,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Kuopio University Hospital","Kuopio","Northern Savonia","70200",{"type":72,"coordinates":93},[94,95],27.67703,62.89238,{"lat":95,"lon":94},[98,101,102,104],{"name":46,"role":56,"phone":99,"phoneExt":26,"email":100},"‭+358400911568‬","nils.danner@pshyvinvointialue.fi",{"name":46,"role":38,"phone":26,"phoneExt":26,"email":26},{"name":103,"role":84,"phone":26,"phoneExt":26,"email":26},"Ville Leinonen, MD, PhD",{"name":105,"role":84,"phone":26,"phoneExt":26,"email":26},"Timo Koivisto, MD, PhD",{"facility":107,"status":65,"city":108,"state":109,"zip":110,"country":69,"countryCode":70,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Tampere University Hospital","Tampere","Pirkanmaa","33520",{"type":72,"coordinates":112},[113,114],23.78712,61.49911,{"lat":114,"lon":113},[117,120,121],{"name":43,"role":56,"phone":118,"phoneExt":26,"email":119},"‭+35840703 9696‬","teemu.luoto@pirha.fi",{"name":43,"role":38,"phone":26,"phoneExt":26,"email":26},{"name":122,"role":84,"phone":26,"phoneExt":26,"email":26},"Minna J Rauhala, MD, PhD",{"facility":124,"status":65,"city":125,"state":126,"zip":127,"country":69,"countryCode":70,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Turku University Hospital","Turku","Southwest Finland","20520",{"type":72,"coordinates":129},[130,131],22.26869,60.45148,{"lat":131,"lon":130},[134,137,138],{"name":40,"role":56,"phone":135,"phoneExt":26,"email":136},"‭+358443804143‬","jussi.posti@tyks.fi",{"name":40,"role":38,"phone":26,"phoneExt":26,"email":26},{"name":139,"role":84,"phone":26,"phoneExt":26,"email":26},"Dan Laukka, MD, PhD",{"facility":141,"status":142,"city":143,"state":144,"zip":145,"country":69,"countryCode":70,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Helsinki University Hospital","RECRUITING","Helsinki","Uusimaa","00260",{"type":72,"coordinates":147},[148,149],24.93545,60.16952,{"lat":149,"lon":148},[152,153,154,156,158,160,162,164,166,168,169],{"name":33,"role":56,"phone":57,"phoneExt":26,"email":58},{"name":37,"role":56,"phone":60,"phoneExt":26,"email":61},{"name":155,"role":84,"phone":26,"phoneExt":26,"email":26},"Pihla Tommiska, MD, PhD",{"name":157,"role":84,"phone":26,"phoneExt":26,"email":26},"Miikka Korja, MD, PhD",{"name":159,"role":84,"phone":26,"phoneExt":26,"email":26},"Riku Kivisaari, MD, PhD",{"name":161,"role":84,"phone":26,"phoneExt":26,"email":26},"Teemu Luostarinen, MD, PhD",{"name":163,"role":84,"phone":26,"phoneExt":26,"email":26},"Jyri J Virta, MD, PhD",{"name":165,"role":84,"phone":26,"phoneExt":26,"email":26},"Simo Taimela, MD, PhD",{"name":167,"role":84,"phone":26,"phoneExt":26,"email":26},"Teppo LN Järvinen, MD, PhD",{"name":33,"role":38,"phone":26,"phoneExt":26,"email":26},{"name":37,"role":38,"phone":26,"phoneExt":26,"email":26},{"facility":53,"status":65,"city":171,"state":172,"zip":173,"country":174,"countryCode":175,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Stockholm","Region Stockholm","17164","Sweden","SE",{"type":72,"coordinates":177},[178,179],18.06871,59.32938,{"lat":179,"lon":178},[182,185,186,188],{"name":52,"role":56,"phone":183,"phoneExt":26,"email":184},"+46707948670‬","jiri.bartek@regionstockholm.se",{"name":52,"role":38,"phone":26,"phoneExt":26,"email":26},{"name":187,"role":84,"phone":26,"phoneExt":26,"email":26},"Alexander Fletcher-Sandersjöö, MD, PhD",{"name":189,"role":84,"phone":26,"phoneExt":26,"email":26},"Bjartur Saemundsson, MD",{"type":191,"investigatorFullName":192,"investigatorTitle":193,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Rahul Raj","Sponsor Principal Investigator",[195,196,197,199,200],{"name":107,"class":6},{"name":88,"class":6},{"name":124,"class":198},"OTHER_GOV",{"name":64,"class":6},{"name":53,"class":6},"100569579","restarting-early-versus-later-anticoagulation-for-chronic-subdural-hematoma-with-atrial-fibrillation-100569579",false,"NCT06696079","Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation","Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation (RELACS): An International Multicenter, Randomized Controlled, Two-arm, Assessor-blinded, Trial","RELACS","Inclusion Criteria:\n\n* Age ≥18 years.\n* Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation with drainage (CSDH is predominantly hypodense or isodense on imaging \\[CT\u002FMRI\\]; clinical symptoms attributable to the CSDH; patients with bilaterally operated CSDHs will be treated with the same protocol on both sides and analyzed as a single study participant).\n* Patients that are on an oral anticoagulation medication due to permanent, persistent or paroxysmal spontaneous atrial fibrillation previously known\n* Randomization done within 4 days of the surgery\n\nExclusion Criteria:\n\n* Intraoperative or immediate postoperative hemorrhagic complication\n* CSDH requiring surgical treatment other than burr-hole evacuation (e.g. craniotomy)\n* Prior CSDH surgery within 12 months\n* Cerebrospinal fluid shunt\n* CSDH is in an arachnoid cyst\n* If the operated hematoma is revealed to be a cerebrospinal fluid collection (hygroma)\n* Conditions other than atrial fibrillation that require anticoagulation, including therapeutical dose of low molecular-weight heparin or heparin (for example, pulmonary embolism, deep vein thrombosis, hypercoagulability syndromes)\n* Mechanical heart valve(s)\n* Moderate or severe mitral stenosis (other valvular diseases and biological valves are eligible)\n* Contraindication to anticoagulation medication (for example bleeding disorder, documented high risk of fall \\[e.g. due to severe alcoholism\\], severe thrombocytopenia, severe anemia)\n* Concomitant use of antiplatelet medication\n* Moderate to severe renal insufficiency (creatinine clearance \\\u003C30 ml\u002Fmin or on dialysis)\n* Not a permanent resident in Finland (for Finnish patients) or not a permanent resident in Region Stockholm (for Swedish patients)","ALL","18 Years",{"count":212,"type":213},332,"ESTIMATED","INTERVENTIONAL",[216],"NA","The goal of this randomized clinical trial is to assess the benefit of early resumption versus late resumption of oral anticoagulation medication in adults with atrial fibrillation undergoing surgery for chronic subdural hematoma. The main questions it aims to answer are:\n\n* Does anticoagulation resumption 5 days after surgery as compared to 30 days after surgery result in fewer thromboembolic complications, without increasing the risk for bleeding?\n* Does anticoagulation resumption 5 days after surgery as compared to 30 days after surgery affect the risk of reoperation, functional outcome, mortality, and healthcare use?\n\nResearchers will compare early anticoagulation resumption (5 days) and late anticoagulation resumption (30 days) after chronic subdural hematoma surgery.\n\nParticipants will either resume the medication 5 days or 30 days after the surgery. The participants will be followed up for 3 months after the surgery.",[219,220],"Chronic Subdural Hematoma","Atrial Fibrillation (AF)",[222,223,224,225,226,227,228,229,230],"chronic subdural hematoma","atrial fibrillation","oral anticoagulation","warfarin","direct oral anticoagulants","surgery","stroke","hemorrhage","prognosis","2025-08-21",{"date":233,"type":234},"2025-08-22","ACTUAL",{"date":236,"type":234},"2025-07-07",{"date":238,"type":213},"2027-06",{"name":192,"class":6},6]