The purpose of this study is to determine if additional interventions will assist with decreasing the risk and/or severity of thromboembolism (clotting complications) in patients who have experienced a major traumatic event.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
314
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.
Normal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight.
University of Colorado
Aurora, Colorado, United States
Jackson Memorial Hospital/University of Miami
Miami, Florida, United States
Vanderbilt University Hospital
Nashville, Tennessee, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of participants with incidences of venous thromboembolism (VTE )
Time frame: 14 days post hospital admission
Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU/mL
Time frame: 14 days post hospital admission
Time taken to achieve anti-FXa of ≥0.2 IU/mL
Time frame: 14 days post hospital admission
Number of enoxaparin dose escalations
Time frame: 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)
Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Number of incidences of participants with bleeding events (interoperative bleeding, abdominal bleeding)
Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Number of hospital free days
Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Number of Ventilator free days
Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Number of ICU free days
Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
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Level of Anti-FXa
Time frame: from the time of hospital admission up to hospital day 7
Antithrombin (AT) activity level
Time frame: 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 frame: 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
Time frame: 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
Time frame: From time of hospital admission to day 7
Change in level of Inflammatory marker Interleukin-8 (IL-8) as assessed by a blood test
Time frame: 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 frame: 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
Time frame: From time of hospital admission to day 7
Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test
Time frame: From time of hospital admission to day 7
Change in level of Inflammatory marker Interferon -gamma (INFg) as assessed by a blood test
Time frame: From time of hospital admission to day 7
Number of participants with In-hospital mortality
Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)