Enrolling by invitation NCT05794165
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thrombate infusion, Placebo.
- Who it may be relevant to
- Registry conditions: Trauma Injury, Thromboembolism, Venous Thromboembolism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism (TRAIT)
Overview
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.
Interventions
- 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. - Drug Placebo
Normal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight.
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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)]
- 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]
Eligibility criteria
Inclusion criteria
- Admission to trauma service
- Polytraumatic injuries OR pelvic/long bone fracture
- Planned admission to trauma ICU or step-down/SIMU setting (this includes STICU, SIMU/TIMU, BICU, and BIMU)
- Informed consent obtained
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- University of Colorado — Aurora
- Jackson Memorial Hospital/University of Miami — Miami
- Vanderbilt University Hospital — Nashville
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT05794165 · HSC-MS-22-1102