[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611798":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":36,"locations":45,"responsibleParty":64,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":18,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":48,"whyStopped":18,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"St. Olavs Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard surgical treatment with adjunctive treatment with tranexamic acid","ACTIVE_COMPARATOR","Surgical evacuation with tranexamic acid. Preoperative administration of 1g IV with additional 1g administrated postoperatively. Followed by 500mg two times a day for a total of 28 days.",[13],"Drug: Tranexamic Acid (Cyklokapron)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard surgical treatment","NO_INTERVENTION","Surgically evacuation of chronic subdural hematoma without adjuntive medical therapy",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Tranexamic Acid (Cyklokapron)","Patients randomized to the treatment group will receive 1g of TXA pre and postoperative intravenously administrated followed by a 28 days treatment course of 500mg x2 of TXA orally",[9],[26,30,34],{"name":27,"affiliation":28,"role":29},"Chandrashekhar Gendle, MD PhD","Postgraduate Institute of Medical Education & Research (PGIMER)","STUDY_CHAIR",{"name":31,"affiliation":32,"role":33},"Mattis A Madsbu, MD PhD","St. Olavs University Hospital, Department of Neurosurgery","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":32,"role":29},"Sasha Gulati, Professor",[37,41],{"name":27,"role":38,"phone":39,"phoneExt":18,"email":40},"CONTACT","+91 98781 52589","chandrashekhargonde@gmail.com",{"name":42,"role":38,"phone":43,"phoneExt":18,"email":44},"Pravin Salunke, Professor, MD","+91 99155 04994","drpravin_salunke@yahoo.co.uk",[46],{"facility":47,"status":48,"city":49,"state":18,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Post Graduate Institute of Medical Education & Research","RECRUITING","Chandigarh","160012","India","IN",{"type":54,"coordinates":55},"Point",[56,57],76.7884,30.73629,{"lat":57,"lon":56},[60,63],{"name":61,"role":38,"phone":62,"phoneExt":18,"email":44},"Pravin Salunke, Professor","+91 99155 04 994",{"name":61,"role":33,"phone":18,"phoneExt":18,"email":18},{"type":65,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[67],{"name":68,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","100611798","phase-2-adjuvant-tranexamic-acid-txa-versus-surgery-alone-for-adult-patients-with-chronic-subdural-hematoma-csdh-100611798",false,"NCT07245264","Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH)","Randomized Trial Comparing Adjuvant Tranexamic Acid Versus Surgery Alone For Chronic Subdural Hematoma","RATATA","Inclusion Criteria:\n\n1. Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm thickness.\n2. Adult patient ≥18 years\n3. Scheduled for single or double burr hole for evacuation.\n4. No contraindication for TXA\n\nExclusion criteria\n\n1. Mechanical heart valve\n2. Newly diagnosed (last 12 months) pulmonary embolism, myocardial infarction, and strong indication for antithrombotic treatment\n3. Intracranial surgery within last 6 months\n4. Pregnancy and woman\\\u003C40 years\n5. Participation in any other clinical trial\n6. Life expectancy of less than one year.\n7. A score on the modified Rankin scale, designed to assess functional independence, of 4 or 5 (scores range from 0 \\[no symptoms\\] to 6 \\[death\\]) before the hematoma occurred.\n8. Unfit for participations for any other reason as evaluated by the including physician.\n9. History of severe impairment of renal function (eGFR \\\u003C30ml\u002Fmin or serum creatinine \\>150μmol\u002FL)\n10. Known hypersensitivity or allergy to TXA\n11. Inability to obtain informed consent from the patient or legal representative","ALL","18 Years",{"count":80,"type":81},274,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE2","PHASE3","This study is an open label randomized controlled trial. Patients with a symptomatic Chronic Subdural Hematoma (CSDH) confirmed on radiological imaging, planned for surgery, age over 18, free from other intracranial pathologies and no previous intracranial surgery, will be recruited at time of admission. Patients eligible for inclusion will be randomized to receive treatment with Tranexamic acid (TXA) as an adjunct to surgery or surgery alone. Surgical evacuation will be performed using a single or double burr hole and 24 hours postoperative drainage. The primary endpoint will be recurrent hematoma requiring repeat surgery within 90 days. Secondary outcomes will be modified Rankin Scale at 90 days, EQ-5D-5L, complications and adverse events, and 90-day mortality.",[88],"Chronic Subdural Hematoma",[90,91,92],"Chronic subdural hematoma","Tranexamic acid","Neurosurgery","2025-12-01",{"date":95,"type":96},"2025-12-08","ACTUAL",{"date":98,"type":81},"2025-12-10",{"date":100,"type":81},"2029-06-01",{"name":5,"class":6},1]