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

Bryan Cotton4 sites in 1 country314 target enrollmentSeptember 27, 2023

ConditionsTrauma Injury Thromboembolism Venous Thromboembolism

InterventionsThrombate infusion Placebo

DrugsThrombate infusion Placebo

Overview

Phase: Phase 2
Intervention: Thrombate infusion
Conditions: Trauma Injury
Sponsor: Bryan Cotton
Enrollment: 314
Locations: 4
Primary Endpoint: Number of participants with incidences of venous thromboembolism (VTE )
Status: Enrolling By Invitation
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 27, 2023

End Date

March 2027

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bryan Cotton

Responsible Party

Sponsor Investigator

Principal Investigator

Bryan Cotton

Professor

The University of Texas Health Science Center, Houston

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

Arms & Interventions

Thrombate infusion

Intervention: Thrombate infusion

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Number of participants with incidences of venous thromboembolism (VTE )

Time Frame: 14 days post hospital admission

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

Time Frame: 14 days post hospital admission

Secondary Outcomes

Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test(From time of hospital admission to day 7)
Time taken to achieve anti-FXa of ≥0.2 IU/mL(14 days post hospital admission)
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))
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 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)
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-8 (IL-8) 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)
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))
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))