TRAIT: Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Thrombate infusion
|
Drug: Thrombate infusion
Bolus intravenous infusion of Thrombate will be given to achieve antithrombin (AT) activity levels at 150% after the 3rd dose of Enoxaparin. The dose will be based on patient weight.
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Normal Saline will be given as one time IV after the 3rd dose of Enoxaparin. The dose will be based on patient weight.
|
Outcome Measures
Primary Outcome Measures
- Number of participants with incidences of venous thromboembolism (VTE ) [14 days post hospital admission]
- Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU/mL [14 days post hospital admission]
Secondary Outcome Measures
- 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)]
- 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)]
- 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]
- Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test [From time of hospital admission to day 7]
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Highest level of trauma activation or upgrade to highest level
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Polytraumatic injuries OR pelvic/long bone fracture
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Admission to trauma ICU or Surgical Intermediate Care Unit (SIMU)
-
Informed consent obtained
Exclusion Criteria:
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Prisoners (defined as those directly admitted from correctional facility)
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Known or suspected pregnancy
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≥ 20% total body surface area (TBSA) burned
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Nonsurvivable head injuries
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Known hematologic or immunologic disorders
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Known prehospital anticoagulant use
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Patients initially placed on unfractionated heparin for thromboprophylaxis
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Known allergy to Antithrombin or it's components
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Enrollment in another interventional study unless approved by Trial Principal Investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- Grifols Therapeutics LLC
Investigators
- Principal Investigator: Bryan A Cotton, MD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-22-1102