[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05794165":3,"trial-entities:NCT05794165":153,"trial-summary:NCT05794165":157},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":46,"sex":88,"minimum_age":89,"maximum_age":17,"healthy_volunteers":90,"eligibility_criteria":91,"std_ages":108,"locations":111,"central_contacts":145,"overall_officials":146,"references":151,"see_also_links":152},"NCT05794165","HSC-MS-22-1102","Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism","Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism (TRAIT)","ENROLLING_BY_INVITATION","2027-03","2025-05","2025-05-14","2023-09-27","Bryan Cotton","OTHER",true,"The purpose of this study is to determine if additional interventions will assist with decreasing the risk and\u002For severity of thromboembolism (clotting complications) in patients who have experienced a major traumatic event.",null,[19,20,21],"Trauma Injury","Thromboembolism","Venous Thromboembolism",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},314,"ESTIMATED",[31,36],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Thrombate infusion","Bolus intravenous infusion of Thrombate will be given to achieve antithrombin (AT) activity levels at 150% before the 3rd dose of Enoxaparin. The dose will be based on patient weight.",[33],{"type":32,"name":37,"description":38,"armGroupLabels":39},"Placebo","Normal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight.",[37],[41,44],{"measure":42,"timeFrame":43},"Number of participants with incidences of venous thromboembolism (VTE )","14 days post hospital admission",{"measure":45,"timeFrame":43},"Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU\u002FmL",[47,49,52,54,56,58,60,62,65,67,70,73,76,78,80,82,84,86],{"measure":48,"timeFrame":43},"Time taken to achieve anti-FXa of ≥0.2 IU\u002FmL",{"measure":50,"timeFrame":51},"Number of enoxaparin dose escalations","from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)",{"measure":53,"timeFrame":51},"Number of incidences of participants with other thrombotic complications (arterial thrombosis, myocardial infarction, stroke)",{"measure":55,"timeFrame":51},"Number of incidences of participants with bleeding events (interoperative bleeding, abdominal bleeding)",{"measure":57,"timeFrame":51},"Number of hospital free days",{"measure":59,"timeFrame":51},"Number of Ventilator free days",{"measure":61,"timeFrame":51},"Number of ICU free days",{"measure":63,"timeFrame":64},"Level of Anti-FXa","from the time of hospital admission up to hospital day 7",{"measure":66,"timeFrame":64},"Antithrombin (AT) activity level",{"measure":68,"timeFrame":69},"Change in level of the endothelial marker syndecan-1 as assessed by a blood test","time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7",{"measure":71,"timeFrame":72},"Change in level of the endothelial marker thrombomodulin as assessed by a blood test","From the time of hospital admission to day 7",{"measure":74,"timeFrame":75},"Change in level of Inflammatory marker Tumor necrosis factor alpha (TNFα) as assessed by a blood test","From time of hospital admission to day 7",{"measure":77,"timeFrame":75},"Change in level of Inflammatory marker Interleukin-8 (IL-8) as assessed by a blood test",{"measure":79,"timeFrame":69},"Change in level of Inflammatory marker Interleukin-6(IL-6) as assessed by a blood test",{"measure":81,"timeFrame":75},"Change in level of Inflammatory marker Interleukin-1 beta (IL1b) as assessed by a blood test",{"measure":83,"timeFrame":75},"Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test",{"measure":85,"timeFrame":75},"Change in level of Inflammatory marker Interferon -gamma (INFg) as assessed by a blood test",{"measure":87,"timeFrame":51},"Number of participants with In-hospital mortality","ALL","18 Years",false,{"inclusion":92,"exclusion":97,"raw_text":107},[93,94,95,96],"Admission to trauma service","Polytraumatic injuries OR pelvic\u002Flong bone fracture","Planned admission to trauma ICU or step-down\u002FSIMU setting (this includes STICU, SIMU\u002FTIMU, BICU, and BIMU)","Informed consent obtained",[98,99,100,101,102,103,104,105,106],"Prisoners (defined as those directly admitted from correctional facility)","Known or suspected pregnancy","≥ 20% total body surface area (TBSA) burned","Nonsurvivable head injuries","Known hematologic or immunologic disorders","Known prehospital anticoagulant use","Patients initially placed on unfractionated heparin for thromboprophylaxis","Known allergy to Antithrombin or it's components","Enrollment in another interventional study unless approved by Trial Principal Investigator","Inclusion Criteria:\n\n* Admission to trauma service\n* Polytraumatic injuries OR pelvic\u002Flong bone fracture\n* Planned admission to trauma ICU or step-down\u002FSIMU setting (this includes STICU, SIMU\u002FTIMU, BICU, and BIMU)\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Prisoners (defined as those directly admitted from correctional facility)\n* Known or suspected pregnancy\n* ≥ 20% total body surface area (TBSA) burned\n* Nonsurvivable head injuries\n* Known hematologic or immunologic disorders\n* Known prehospital anticoagulant use\n* Patients initially placed on unfractionated heparin for thromboprophylaxis\n* Known allergy to Antithrombin or it's components\n* Enrollment in another interventional study unless approved by Trial Principal Investigator",[109,110],"ADULT","OLDER_ADULT",[112,121,129,137],{"facility":113,"city":114,"state":115,"zip":116,"country":117,"geoPoint":118},"University of Colorado","Aurora","Colorado","80045","United States",{"lat":119,"lon":120},39.72943,-104.83192,{"facility":122,"city":123,"state":124,"zip":125,"country":117,"geoPoint":126},"Jackson Memorial Hospital\u002FUniversity of Miami","Miami","Florida","33136",{"lat":127,"lon":128},25.77427,-80.19366,{"facility":130,"city":131,"state":132,"zip":133,"country":117,"geoPoint":134},"Vanderbilt University Hospital","Nashville","Tennessee","37212",{"lat":135,"lon":136},36.16589,-86.78444,{"facility":138,"city":139,"state":140,"zip":141,"country":117,"geoPoint":142},"The University of Texas Health Science Center at Houston","Houston","Texas","77030",{"lat":143,"lon":144},29.76328,-95.36327,[],[147],{"name":148,"affiliation":149,"role":150},"Bryan A Cotton, MD","The University of Texas Health Science Center, Houston","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":154,"biomarkers":156},[155,21],"Injury",[],{"nct_id":4,"found":90,"summary":17,"prompt_version":17}]