Thromboembolism, Trauma Injury, Venous Thromboembolism
Conditions
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.
Interventions
DRUGThrombate 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.
DRUGPlacebo
Normal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight.
Sponsors
Grifols Shared Services North America, Ind.
Bryan Cotton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This will be a double-blind study.
Intervention model description
Multi-center, placebo-controlled, randomized, double-blind study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Inflammatory marker Interleukin-8 (IL-8) as assessed by a blood test | From time of hospital admission to 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-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) |
| 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 |
| Time taken to achieve anti-FXa of ≥0.2 IU/mL | 14 days post hospital admission |
Countries
United States
Outcome results
None listed