[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540790":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":173,"collaborators":176,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":181,"sex":187,"minAge":188,"maxAge":18,"enrollmentInfo":189,"targetDuration":18,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Advanced Trauma Life Support","EXPERIMENTAL","The intervention will be ATLS® training, a proprietary 2.5 day course teaching a standardised approach to trauma patient care using the concepts of a primary and secondary survey. Physicians will be trained in an accredited ATLS® training facility in India.",[13],"Behavioral: Advanced Trauma Life Support training",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","NO_INTERVENTION","Standard care varies across hospitals in India, but trauma patients are initially managed by casualty medical officers, surgical residents, or emergency medicine residents. They are mainly first- or second-year residents who resuscitate patients, perform interventions and refer patients for imaging or other investigations. Compared with other settings where a trauma team approach is adopted, nurses and other healthcare professionals are only involved to a limited extent during the initial management.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Advanced Trauma Life Support training","Advanced Trauma Life Support (ATLS) is a proprietary 2.5 day course teaching a standardised approach to trauma patient care using the concepts of a primary and secondary survey. The programme was developed by the Committee of Trauma of the American College of Surgeons. The course includes intial treatment and resuscitation, triage and interfacility transfers. Leaning is based on practical scenario-driven skill stations, lectures and includes a final performance proficiency evaluation. Physicians will be trained in an accredited ATLS training facility in India.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Martin Gerdin Wärnberg, PhD","CONTACT","+46708539598","martin.gerdin@ki.se",[32,51,65,76,89,103,118,129,144,159],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Assam Medical College & Hospital","RECRUITING","Dibrugarh","Assam","786003","India","IN",{"type":41,"coordinates":42},"Point",[43,44],94.90837,27.47989,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":18,"email":50},"Jishan Ahmed","+919435031369","dr.jishan@gmail.com",{"facility":52,"status":34,"city":53,"state":54,"zip":55,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"KEM Hospital","Mumbai","Maharashtra","400012",{"type":41,"coordinates":57},[58,59],72.88261,19.07283,{"lat":59,"lon":58},[62],{"name":63,"role":28,"phone":18,"phoneExt":18,"email":64},"Monty Khajanchi","monta32@gmail.com",{"facility":66,"status":34,"city":53,"state":54,"zip":67,"country":38,"countryCode":39,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Lokmanya Tilak Municipal General Hospital","400022",{"type":41,"coordinates":69},[58,59],{"lat":59,"lon":58},[72],{"name":73,"role":28,"phone":74,"phoneExt":18,"email":75},"Vineet Kumar","+91 982023133","drvineetkumar@gmail.com",{"facility":77,"status":34,"city":53,"state":54,"zip":78,"country":38,"countryCode":39,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},"Hridaysamrat Balasaheb Thackre Mun. Medical college and Dr. R.N. Cooper Hospital","400056",{"type":41,"coordinates":80},[58,59],{"lat":59,"lon":58},[83,86],{"name":84,"role":85,"phone":18,"phoneExt":18,"email":18},"Geeta Ghag, MS General Surgery","PRINCIPAL_INVESTIGATOR",{"name":87,"role":88,"phone":18,"phoneExt":18,"email":18},"Vipul Nandu, MS General Surgery","SUB_INVESTIGATOR",{"facility":90,"status":34,"city":91,"state":91,"zip":92,"country":38,"countryCode":39,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Holy Family Hospital","New Delhi","110025",{"type":41,"coordinates":94},[95,96],77.2148,28.62137,{"lat":96,"lon":95},[99],{"name":100,"role":28,"phone":101,"phoneExt":18,"email":102},"Aisvarya Kapoor","+919999139808","aisvarya.kapoor@gmail.com",{"facility":104,"status":34,"city":105,"state":106,"zip":107,"country":38,"countryCode":39,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Dayanand Medical College & Hospital","Ludhiana","Punjab","141001",{"type":41,"coordinates":109},[110,111],75.85379,30.91204,{"lat":111,"lon":110},[114],{"name":115,"role":28,"phone":116,"phoneExt":18,"email":117},"Jaspal Singh","+919815599527","jaspalselhi@gmail.com",{"facility":119,"status":34,"city":105,"state":106,"zip":120,"country":38,"countryCode":39,"cosmosGeoPoint":121,"geoPoint":123,"contacts":124},"Christian Medical College & Hospital","141008",{"type":41,"coordinates":122},[110,111],{"lat":111,"lon":110},[125,127],{"name":126,"role":85,"phone":18,"phoneExt":18,"email":18},"Parvez Haque, MS General Surgery",{"name":128,"role":88,"phone":18,"phoneExt":18,"email":18},"Thejus Varghese, MD Emergency",{"facility":130,"status":34,"city":131,"state":132,"zip":133,"country":38,"countryCode":39,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Himalayan Institute of Medical Sciences, Swami Rama Himalayan University","Dehradun","Uttarakhand","248016",{"type":41,"coordinates":135},[136,137],78.03392,30.32443,{"lat":137,"lon":136},[140,142],{"name":141,"role":85,"phone":18,"phoneExt":18,"email":18},"Hemant Nautiyal, MS General Surgery",{"name":143,"role":88,"phone":18,"phoneExt":18,"email":18},"Bhaskar Bisht, MS General Surgery",{"facility":145,"status":34,"city":146,"state":147,"zip":148,"country":38,"countryCode":39,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital (IPGMER and SSKM Hospital)","Kolkata","West Bengal","700020",{"type":41,"coordinates":150},[151,152],88.36304,22.56263,{"lat":152,"lon":151},[155,157],{"name":156,"role":85,"phone":18,"phoneExt":18,"email":18},"Shamita Chatterjee, MS General Surgery",{"name":158,"role":88,"phone":18,"phoneExt":18,"email":18},"Maitreyee Mukherjee, MD Anaesthesiology",{"facility":160,"status":34,"city":161,"state":18,"zip":162,"country":38,"countryCode":39,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Government Medical College Hospital","Chandigarh","160030",{"type":41,"coordinates":164},[165,166],76.7884,30.73629,{"lat":166,"lon":165},[169,171],{"name":170,"role":85,"phone":18,"phoneExt":18,"email":18},"Rajeev Sharma, MS Neurosurgery",{"name":172,"role":88,"phone":18,"phoneExt":18,"email":18},"Zahid Mir, General Surgery",{"type":85,"investigatorFullName":174,"investigatorTitle":175,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Martin Gerdin","Principal Researcher",[177],{"name":178,"class":6},"The George Institute","100540790","effects-of-advanced-trauma-life-support-on-adult-trauma-patient-outcomes-100540790",false,"NCT06321419","Effects of Advanced Trauma Life Support® on Adult Trauma Patient Outcomes","Effects of Advanced Trauma Life Support® Training Compared to Standard Care on Adult Trauma Patient Outcomes: A Cluster Randomised Trial","ADVANCE TRAUMA","Inclusion Criteria:\n\n* age of at least 15 years;\n* trauma occurred less than 48 hours before arrival at the hospital;\n* present to the emergency department of participating hospitals, with a history of trauma defined as having any of the reasons listed in the International Classification of Diseases chapter XX as the reason for presenting;\n* admitted or died between arrival at the hospital and admission, or referred\u002Ftransferred from the emergency department of a participating hospital to another hospital for admission; and\n* managed by a participating cluster in the emergency department.\n\nExclusion Criteria:\n\n* present with isolated limb injuries; or\n* are directly admitted to a ward without being seen by a physician in the emergency department.","ALL","15 Years",{"count":190,"type":191},4320,"ESTIMATED","INTERVENTIONAL",[194],"NA","Rationale:\n\nTrauma is a massive global health issue. Many training programmes have been developed to help physicians in the initial management of trauma patients. Among these programmes, Advanced Trauma Life Support® (ATLS®) is the most popular, having trained over one million physicians worldwide. Despite its widespread use, there are no controlled trials showing that ATLS® improves patient outcomes. Multiple systematic reviews emphasise the need for such trials.\n\nAim:\n\nTo compare the effects of ATLS® training with standard care on outcomes in adult trauma patients.\n\nTrial Population:\n\nAdult trauma patients presenting to the emergency department of a participating hospital.\n\nEligibility Criteria:\n\nHospitals are secondary or tertiary hospitals in India that admit or refer\u002Ftransfer for admission at least 400 patients with trauma per year. Clusters are one or more units of physicians providing initial trauma care in the emergency department of tertiary hospitals in India. Patients participants are adult trauma patients who presents to the emergency department of participating hospitals and are admitted or transferred for admission.\n\nEthical Considerations:\n\nThe study will use an opt-out consent approach for in-hospital collection of routinely recorded data, in which consent is presumed unless actively declined. Informed consent for non-routinely recorded data including out of hospital follow up will be obtained. Patients who are unconscious or lack a legally authorized representative will be included under a waiver of informed consent. Note that consent here refers to consent to data collection, as it will not be possible for patients to opt out from being subjected to the intervention. This approach is justified because the trial can be considered to involve only minimal risk and the data collection is non-invasive and mostly involve extracting routinely collected data from medical records.\n\nFunding:\n\nSwedish Research Council (reg. no. 2023-03128), Laerdal Foundation (reg. no. 2023-0297).\n\nSpecial considerations:\n\nThis trial is not yet fully funded. The Trial Management Group has decided to proceed with the trial with the expectation that additional funding will be secured. The Joint Trial Steering and Data Monitoring Committee will be informed of the funding status at each meeting. If funding is not secured, the trial will be stopped. This will likely result in an underpowered trial. The justification for this decision is that the intervention is considered standard of care in many countries and the data collection is considered minimal risk. There is therefore a very small risk of harm to patient participants, but a potential direct benefit to those.",[197],"Wounds and Injuries",[9,199,200,201,202],"Mortality","Disability","Return to work","Quality of Life","2026-01-21",{"date":205,"type":206},"2026-01-23","ACTUAL",{"date":208,"type":206},"2025-02-27",{"date":210,"type":191},"2029-11",{"name":5,"class":6},10]