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

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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

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

Trial contacts and locations

0

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Central trial contact

Jeanette M Podbielski; Bryan A Cotton, MD

Data sourced from clinicaltrials.gov

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