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

Launched by BRYAN COTTON · Mar 28, 2023

Keywords

ClinConnect Summary

The TRAIT trial is studying whether giving a short infusion of antithrombin (called Thrombate) before the third dose of the standard blood thinner enoxaparin can lower the risk of blood clots in people who have experienced major trauma. It is a multicenter, randomized, double-blind study, meaning participants are randomly assigned to receive either Thrombate or a placebo, and neither the patient nor the care team knows which one is given. The main questions are how many people develop a venous clot within about 14 days of hospital admission and how quickly anti-Factor Xa (a lab measure used to gauge blood thinner effect) reaches a target level. Researchers will also look at other outcomes such as bleeding, other clot-related events, hospital and ICU days, ventilator-free days, and several blood tests and markers of inflammation.

If you are eligible, you would be an adult (18 or older) admitted for trauma with multiple injuries or a pelvic/long-bone fracture and planned for care in a trauma ICU or similar unit, and you must be able to give informed consent. Key exclusions include prisoners, pregnancy, large burns, very severe head injury, certain blood disorders, prior use of certain anticoagulants, or participation in another interventional trial unless approved. If enrolled, you would receive either Thrombate infusion or a placebo just before the third enoxaparin dose, in addition to standard care, with blood tests and follow-up during your hospital stay and up to about 30 days to monitor clotting, bleeding, and recovery. The study is currently enrolling by invitation across several U.S. centers and plans to enroll about 314 participants, with completion expected in 2027.

Gender

ALL

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