Clinical trial NCT05794165: Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
Official title: Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism (TRAIT)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Trauma Injury
Thromboembolism
Venous Thromboembolism
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Grifols Shared Services North America, Ind.
First posted: 2023-04-03
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, placebo-controlled, randomized, double-blind study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants with incidences of venous thromboembolism (VTE )
timeFrame: 14 days post hospital admission
measure: Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU/mL
timeFrame: 14 days post hospital admission
Secondary outcomes:
measure: Time taken to achieve anti-FXa of ≥0.2 IU/mL
timeFrame: 14 days post hospital admission
measure: Number of enoxaparin dose escalations
timeFrame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
measure: Number of incidences of participants with other thrombotic complications (arterial thrombosis, myocardial infarction, stroke)
timeFrame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
measure: Number of incidences of participants with bleeding events (interoperative bleeding, abdominal bleeding)
timeFrame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
measure: Number of hospital free days
timeFrame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
measure: Number of Ventilator free days
timeFrame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
measure: Number of ICU free days
timeFrame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
measure: Level of Anti-FXa
timeFrame: from the time of hospital admission up to hospital day 7
measure: Antithrombin (AT) activity level
timeFrame: from the time of hospital admission up to hospital day 7
measure: Change in level of the endothelial marker syndecan-1 as assessed by a blood test
timeFrame: time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7
measure: Change in level of the endothelial marker thrombomodulin as assessed by a blood test
timeFrame: From the time of hospital admission to day 7
measure: Change in level of Inflammatory marker Tumor necrosis factor alpha (TNFα) as assessed by a blood test
timeFrame: From time of hospital admission to day 7
measure: Change in level of Inflammatory marker Interleukin-8 (IL-8) as assessed by a blood test
timeFrame: From time of hospital admission to day 7
measure: Change in level of Inflammatory marker Interleukin-6(IL-6) as assessed by a blood test
timeFrame: time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7
measure: Change in level of Inflammatory marker Interleukin-1 beta (IL1b) as assessed by a blood test
timeFrame: From time of hospital admission to day 7
measure: Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test
timeFrame: From time of hospital admission to day 7
measure: Change in level of Inflammatory marker Interferon -gamma (INFg) as assessed by a blood test
timeFrame: From time of hospital admission to day 7
measure: Number of participants with In-hospital mortality
timeFrame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Miami
country: United States
facility: Jackson Memorial Hospital/University of Miami
state: Florida
city: Nashville
country: United States
facility: Vanderbilt University Hospital
state: Tennessee
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Bryan A Cotton, MD
role: PRINCIPAL_INVESTIGATOR
References: