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

The University of Texas System (UT)

Status and phase: Invitation-only; Phase 2

Conditions: Venous Thromboembolism; Thromboembolism; Trauma Injury

Treatments: Drug: Placebo; Drug: Thrombate infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05794165

HSC-MS-22-1102

Details and patient eligibility

About

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.

Enrollment: 314 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Highest level of trauma activation or upgrade to highest level
• Polytraumatic injuries OR pelvic/long bone fracture
• Admission to trauma ICU or Surgical Intermediate Care Unit (SIMU)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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314 participants in 2 patient groups, including a placebo group

Thrombate infusion

Experimental group

Treatment:

Drug: Thrombate infusion

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo