[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatic-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatic-injury":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,50,79,108,135,160,184,219],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100641098","early-intervention-to-prevent-development-of-ptsd-in-burn-survivors-and-their-caregivers-100641098",false,"NCT07656545","Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers","Inclusion Criteria:\n\n* Alert, oriented, \\& not withdrawing from substance at time of screening\n* Can read and write in English\n* Hospitalized within 10 days of burn injury\n* Anticipated discharge \\\u003C=4 weeks\n* Have an email, mailing address, and at least 1 smart device for telehealth sessions\n* PTSD risk score of 2 or greater (patient-only)\n* Willing to attend therapy sessions with a loved one\n\nExclusion Criteria:\n\n* Currently incarcerated or in police custody\n* \\> 10 days post-burn\n* Lifetime diagnosis of primary psychosis or intellectual disability\n* Ongoing reported domestic violence in the dyad\n* Unstable bipolar disorder, severe substance use disorder, or acute suicidality with imminent intent that does not remit within 10 days of burn-injury\n* Inflammation Confounds (patient-only) of BMI \\> 40, metabolic syndrome, admission A1C of \\>= 6.5%\n* Currently receiving couples therapy",true,"ALL","18 Years",{"count":19,"type":20},44,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this clinical trial is to adapt and test a brief patient-caregiver early intervention designed to reduce posttraumatic stress symptoms in hospitalized burn patients and their caregivers. This intervention is a brief, 4-session cognitive-behavioral intervention designed for burn patients and their loved one to complete together, during and after hospitalization. The intervention targets relational communication and functioning through reduction of invalidating, negative statements and avoidant coping by teaching patients and their loved ones to engage in adaptive natural disclosures, supportive responses, and approach coping after the burn trauma. The intervention uses evidence-based psychotherapy techniques, including psychoeducation, motivational interviewing, and skills coaching. The clinical trial will occur in two sequential phases. In the first phase of the study (case series), the intervention will be provided to two burn patient-caregiver dyads (four adults) to pilot test the intervention, seek patient and provider feedback, and refine the intervention. All four adults will receive the intervention. In the second phase of the study, the randomized controlled trial (RCT) phase, investigators will enroll 20 more burn patient-caregiver dyads (40 more adults) who will be randomly assigned (like the flip of a coin) at the dyad level to receive the intervention or a burn survivor-only minimally enhanced usual care psychoeducation control condition (mEUC). The goals of the RCT phase are to study whether the intervention is acceptable to patients, feasible to conduct, and whether the intervention improves burn survivor-caregiver healthy relationship communication about difficult events and treatment outcomes compared to mEUC.",[26,27,28,29,30,31,32,33,34,35,36],"Posttraumatic Stress Disorder","Burns","Traumatic Injury","Acute Stress Disorder","Trauma and Stressor Related Disorders","Trauma and Stress Related Disorders","Stress Disorder","Stress Disorders, Post-Traumatic","Stress Disorders, Traumatic","Stress Disorders, Traumatic, Acute","Relationship, Social","NOT_YET_RECRUITING","2026-06-14",{"date":40,"type":41},"2026-06-18","ACTUAL",{"date":43,"type":20},"2026-08-01",{"date":45,"type":20},"2029-02-28",{"name":47,"class":48},"University of Southern California","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":49},"100544238","pediatric-and-caregiver-traumatic-stress-intervention-pacts-100544238","NCT06366282","Pediatric and Caregiver Traumatic Stress Intervention (PACTS)","Pediatric and Caregiver Traumatic Stress Intervention: A Path Forward After Injury for Pediatric Survivors and Their Caregivers","PACTS","Inclusion Criteria:\n\n* Child requires inpatient treatment for an unintentional injury (e.g. burns, dog bite, road traffic accident) in the pediatric trauma and\u002For pediatric burns units\n* English-speaking adults, with English denoted as the primary language in the electronic medical record (EMR)\n* Caregiver-child dyads who screen positive with the Peritraumatic Distress Inventory (PDI) Tools will be invited to participate in the randomized controlled trial.\n\nExclusion Criteria:\n\n* Patients and\u002For caregivers with cognitive deficits, with psychotic symptoms, refusing treatment, and leaving the hospital against medical advice (AMA) were unable to participate in counseling interventions by condition or by choice and are excluded from the study population","1 Year","6 Years",{"count":61,"type":20},24,[23],"The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and\u002For depression.",[28],[66,67,68],"posttraumatic stress disorder","depression","pediatric injury","RECRUITING","2026-04-01",{"date":72,"type":41},"2026-04-06",{"date":74,"type":41},"2024-11-26",{"date":76,"type":20},"2026-07",{"name":78,"class":48},"Wake Forest University Health Sciences",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100472875","phase-3-prehospital-analgesia-intervention-trial-pain-100472875","NCT05437575","Prehospital Analgesia INtervention Trial (PAIN)","PAIN","Inclusion Criteria:\n\n* Transport after injury to a participating PAIN Trauma center\n* 2\\. Patient with compensated shock as defined by Shock Index (SI) ≥0.9 or Heart Rate (HR) ≥115.\n* Intravenous pain medication indicated (CPOT≥2, NRS≥5) prior to arrival at the trauma center\n\nExclusion Criteria:\n\n* No IV access\n* Age \\\u003C18 years\n* Females \\\u003C50 years of age\n* SBP\\>180 mmHg at time of enrollment\n* Advanced airway management prior to first dose administration\n* Known allergy to fentanyl citrate or ketamine hydrochloride\n* Known prisoner\n* Objection to study voiced by subject or family member at scene\n* Pain treatment contraindicated by local protocol\n* Wearing a \"NO PAIN STUDY\" bracelet",{"count":87,"type":20},994,[89],"PHASE3","The Prehospital Analgesia INtervention trial (PAIN) is a proposed 4 year (3-year enrollment) multicenter, prehospital, randomized, double-blind, clinical trial that will enroll approximately 994 patients at select LITES Network sites. The objective is to perform a prospective, interventional, randomized trial among prehospital trauma patients with compensated shock (SI≥0.9 or HR ≥115) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.",[28],[93,94,95,96,97],"Trauma","ketamine hydrochloride","fentanyl citrate","shock","pain","2026-03-05",{"date":100,"type":41},"2026-03-09",{"date":102,"type":41},"2023-11-27",{"date":104,"type":20},"2029-07",{"name":106,"class":48},"Jason Sperry",11,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100532277","trauma-bpe-prolonged-exposure-therapy-for-injured-individuals-admitted-to-a-level-i-trauma-center-100532277","NCT06210711","Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center","Prevention of Posttraumatic Stress: A Randomized Controlled Trial of Brief Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center","Inclusion Criteria:\n\n* Between the ages of 18 and 75 years old.\n* Admitted to Baylor University Medical Center at Dallas (BUMC), Baylor Scott \\& White Medical Center at Temple (BSWMC), or Froedtert Hospital and the Medical College of Wisconsin (FH\u002FMCW) Level 1 Trauma Center\n\nExclusion Criteria:\n\n* Patients in police custody\n* Patients not fluent in English\n* Patients with severe cognitive impairment\n* Patients who are acutely suicidal\n* Patients with active psychosis","75 Years",{"count":117,"type":20},300,[23],"The purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (PTSD) and a number of other concerns following injury.",[28,121,26],"PTSD",[121,123,124],"Traumatic injury","Posttraumatic stress disorder","2026-02-09",{"date":127,"type":41},"2026-02-11",{"date":129,"type":41},"2024-02-28",{"date":131,"type":20},"2027-09",{"name":133,"class":48},"Baylor Research Institute",3,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100614153","pilot-feasibility-trial-of-a-peer-support-program-for-trauma-survivors-100614153","NCT07275892","Pilot Feasibility Trial of a Peer Support Program for Trauma Survivors","Inclusion Criteria:\n\n* adult patients (18 years+) who have experienced an unintentional traumatic injury resulting in hospitalization at Sunnybrook and who will be discharged to inpatient rehabilitation at St. John's Rehab after acute care.\n* must be able to communicate in English\n\nExclusion Criteria:\n\n* patients who experienced: a) an intentional self-harm injury (because self-harm suggests a history of mental health issues prior to the trauma requiring specific psychiatric supports)\n* patients who experienced: an injury caused by an intimate partner (because these injuries are typically underpinned by chronic exposure to domestic violence which requires interventions that promote patient safety and interrupt the pattern of violence)\n* patients who experienced: a violently-acquired injury (as this patient population already receives specific clinical and social support through Sunnybrook's BReAking the Cycle of Violence with Empathy (BRAVE) program).\n* patients with substantial cognitive impairment and a history of substance misuse if their HCPs indicate that either condition will impede the their ability to provide informed consent and\u002For participate safely in the trial",{"count":142,"type":20},49,[23],"Traumatic injuries from events like car crashes, falls, or fires are a leading cause of disability. Survivors often face not only physical challenges but also long-lasting pain, mental health challenges and difficulty returning to work and family life. Although medical care focuses on physical recovery, survivors frequently report that their emotional and social needs are overlooked and unmet.\n\nPeer support-guidance from people who have lived through similar injuries-can reduce distress and improve coping. However, no programs in Canada currently provide peer support to trauma survivors across their recovery journey, from hospital to rehabilitation to community living.\n\nThe investigators worked with trauma survivors, caregivers, and healthcare providers to co-design a Peer Support Program (PSP) that offers support throughout these stages. This pilot study will test whether the program is feasible and acceptable, and explore its early impact on recovery. Results will guide a future larger trial to expand peer support in trauma care.",[28,27,146,147],"Amputation","Mental Health Outcomes",[149,28],"Peer Support","2025-12-08",{"date":152,"type":41},"2025-12-10",{"date":154,"type":20},"2026-01-01",{"date":156,"type":20},"2027-12-31",{"name":158,"class":48},"Sunnybrook Health Sciences Centre",2,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":15,"sex":16,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":49},"100445924","evaluation-of-trauma-center-based-intervention-for-adolescent-traumatic-injury-survivors-100445924","NCT05086757","Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors","Evaluation of Trauma Center-Based, Technology Enhanced Stepped Care Intervention for Adolescent Traumatic Injury Survivors.","Inclusion Criteria:\n\n* adolescent ages 12-17 admitted following traumatic injury\n* scored significantly on the peritraumatic distress scale (PDI \u002F ITSS)\n\nExclusion Criteria:\n\n* if the injury was self-inflicted\n* injuries are so severe, they prevent participation (e.g., head or spinal cord injuries that prevent verbal communication)","12 Years","17 Years",{"count":117,"type":20},[23],"Pediatric traumatic injury (i.e., injury of sudden onset and severity requiring immediate attention) is the leading cause of death and morbidity among US adolescents and are associated with mental health and health risk outcomes, including posttraumatic stress and depression (affecting between 19-42%), deficits in physical recovery, social functioning and quality of life, which if unaddressed, may contribute to increased use of health care services. The investigators partnered with three accredited Level I and II pediatric trauma centers to conduct a multi-site hybrid 1 effectiveness-implementation trial with 300 adolescent (ages 12-17) traumatic injury patients to assess the extent to which the Trauma Resilience and Recovery Program (TRRP), a scalable and sustainable, technology-enhanced, multidisciplinary stepped model of care, promotes improvement in quality of life and emotional recovery and gather preliminary data on the potential for TRRP to be implemented in other Level I trauma centers. Directly in line with NICHD's Pediatric Trauma and Critical Illness Research and Training (PTCIB) Strategic Research and Training agenda, this study will provide valuable data on the efficacy, preliminary effectiveness and potential for implementation of an innovative, cost-effective, sustainable technology-enhanced intervention designed to address the unique needs of adolescent injury patients and mitigate short- and long-term impact of injury on mental health, quality of life, and overall well-being.",[28,173,26,174],"Technology","Adolescents","2025-08-08",{"date":177,"type":41},"2025-08-11",{"date":179,"type":41},"2022-07-01",{"date":181,"type":20},"2027-08-30",{"name":183,"class":48},"Medical University of South Carolina",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":115,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":203,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":218},"100407660","phase-3-erythropoietin-alfa-to-prevent-mortality-and-reduce-severe-disability-in-critically-ill-trauma-patients-100407660","NCT04588311","ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients","A Randomised, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury","EPO-TRAUMA","Inclusion Criteria: Patients with trauma admitted to the ICU who:\n\n* Are ≥ 18 to ≤ 75 years of age\n* Are \\\u003C 24 hours since primary traumatic injury\n* Are invasively mechanically ventilated\n* Are expected to stay in the ICU ≥ 48 hours\n* Have a haemoglobin not exceeding the upper limit of the applicable normal (ULN) reference range in clinical use at the treating institution\n* Have informed consent from a legal surrogate according to local law\n\nExclusion Criteria: Patients will be excluded from the study if any of the following criteria apply:\n\n* GCS = 3 and fixed dilated pupils\n* Recent history of DVT, PE or other thromboembolic event (within previous 12 months or receiving concomitant anticoagulant treatment for this indication)\n* A chronic hypercoagulable disorder, including known malignancy\n* Treatment with EPO in the last 30 days\n* First dose of study drug unable to be given within 24 hours of primary injury\n* Pregnancy or lactation or 3 months postpartum\n* Expected to die imminently (\\\u003C 24 hours)\n* Known sensitivity to mammalian cell derived products\n* Known contraindication to epoetin alfa\n* End stage renal failure (receives chronic dialysis)\n* Severe pre-existing physical or mental disability or severe co-morbidity that may interfere with the assessment of outcome\n* The treating physician believes it is not in the best interest of the patient to be randomised to this trial",{"count":193,"type":20},2500,[89],"The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients.\n\n2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.",[93,28,197,198,199,200,201,202],"Traumatic Brain Injury","Wounds and Injuries","Penetrating Injury","Blunt Injury","Major Trauma","Multiple Trauma",[204,93,205,123,206,207,208],"Intensive Care Unit","Major trauma","EPO","Erythropoietin","Epoetin alfa","2025-07-14",{"date":211,"type":41},"2025-07-16",{"date":213,"type":41},"2020-11-09",{"date":215,"type":20},"2027-08-31",{"name":217,"class":48},"Australian and New Zealand Intensive Care Research Centre",41,{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":227,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":21,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":49},"100577894","advancing-discussions-using-a-video-based-support-tool-about-end-of-life-care-100577894","NCT06804226","Advancing Discussions Using a Video-based Support Tool About End-of-life Care","Advancing Discussions Using a Video-based Support Tool About End-of-life Care: the ADVISE Project","ADVISE","Inclusion Criteria:\n\n* English or Spanish speaking\n* admitted to any level of care following trauma\n\nExclusion Criteria:\n\n* Prisoners\n* Existing do not resuscitate (DNR)\u002Fdo not intubate (DNI)\n* Patients admitted while on hospice\n* Patients not expected to survive over 24-48 hours","65 Years",{"count":229,"type":20},270,[23],"The purpose of this study is to evaluate the effectiveness and implementation considerations of a video aid to improve communication and patient-centered outcomes in older injured adults",[28],"2025-03-25",{"date":235,"type":41},"2025-03-30",{"date":237,"type":41},"2025-03-17",{"date":239,"type":20},"2026-06-01",{"name":241,"class":48},"The University of Texas Health Science Center, Houston"]