Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism (TRAIT)

简要总结

盲法说明

主要结局

次要结局

• Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test(From time of hospital admission to day 7)
• Time taken to achieve anti-FXa of ≥0.2 IU/mL(14 days post hospital admission)
• Number of enoxaparin dose escalations(from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first))
• Number of incidences of participants with other thrombotic complications (arterial thrombosis, myocardial infarction, stroke)(from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first))
• Level of Anti-FXa(from the time of hospital admission up to hospital day 7)
• Antithrombin (AT) activity level(from the time of hospital admission up to hospital day 7)
• 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)
• Change in level of the endothelial marker thrombomodulin as assessed by a blood test(From the time of hospital admission to day 7)
• 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)
• Change in level of Inflammatory marker Interleukin-8 (IL-8) as assessed by a blood test(From time of hospital admission to day 7)
• Change in level of Inflammatory marker Interleukin-6(IL-6) as assessed by a blood test(time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7)
• Change in level of Inflammatory marker Interleukin-1 beta (IL1b) as assessed by a blood test(From time of hospital admission to day 7)
• Number of incidences of participants with bleeding events (interoperative bleeding, abdominal bleeding)(from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first))
• Number of hospital free days(from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first))
• Number of Ventilator free days(from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first))
• Number of ICU free days(from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first))
• Change in level of Inflammatory marker Interferon -gamma (INFg) as assessed by a blood test(From time of hospital admission to day 7)
• Number of participants with In-hospital mortality(from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first))