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Enrolling by Invitation

NCT Number: NCT05794165

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

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.

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Key information

Conditions

Trauma Injury Accidental Injuries Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases Venous Thromboembolism Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thrombate infusion

Drug

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.

Placebo

Drug

Normal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight.

Primary outcomes

  1. Number of participants with incidences of venous thromboembolism (VTE )

    Time frame: 14 days post hospital admission

  2. Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU/mL

    Time frame: 14 days post hospital admission

Secondary outcomes

  1. Time taken to achieve anti-FXa of ≥0.2 IU/mL

    Time frame: 14 days post hospital admission

  2. Number of enoxaparin dose escalations

    Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)

  3. Number of incidences of participants with other thrombotic complications (arterial thrombosis, myocardial infarction, stroke)

    Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)

  4. Number of incidences of participants with bleeding events (interoperative bleeding, abdominal bleeding)

    Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)

  5. Number of hospital free days

    Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)

  6. Number of Ventilator free days

    Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)

  7. Number of ICU free days

    Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)

  8. Level of Anti-FXa

    Time frame: from the time of hospital admission up to hospital day 7

  9. Antithrombin (AT) activity level

    Time frame: from the time of hospital admission up to hospital day 7

  10. Change in level of the endothelial marker syndecan-1 as assessed by a blood test

    Time frame: time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7

  11. Change in level of the endothelial marker thrombomodulin as assessed by a blood test

    Time frame: From the time of hospital admission to day 7

  12. Change in level of Inflammatory marker Tumor necrosis factor alpha (TNFα) as assessed by a blood test

    Time frame: From time of hospital admission to day 7

  13. Change in level of Inflammatory marker Interleukin-8 (IL-8) as assessed by a blood test

    Time frame: From time of hospital admission to day 7

  14. Change in level of Inflammatory marker Interleukin-6(IL-6) as assessed by a blood test

    Time frame: time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7

  15. Change in level of Inflammatory marker Interleukin-1 beta (IL1b) as assessed by a blood test

    Time frame: From time of hospital admission to day 7

  16. Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test

    Time frame: From time of hospital admission to day 7

  17. Change in level of Inflammatory marker Interferon -gamma (INFg) as assessed by a blood test

    Time frame: From time of hospital admission to day 7

  18. Number of participants with In-hospital mortality

    Time frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)

Sponsors and collaborators

Lead sponsor

Bryan Cotton

Other

Collaborators

  • Grifols Shared Services North America, Inc.

Registry information

Official study title

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

Acronym: TRAIT

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 3, 2023
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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