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

Venous Thromboembolism Clinical Trial

— TRAIT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05794165
• Other study ID #: HSC-MS-22-1102
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: September 5, 2023
• Est. completion date: March 2027

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 314
• Est. completion date: March 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Trauma Injury
• Venous Thromboembolism
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Grifols Shared Services North America, Ind.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with incidences of venous thromboembolism (VTE )		14 days post hospital admission
Primary	Number of participants with incidence of antifactor Xa (anti-FXa) of =0.2 IU/mL		14 days post hospital admission
Secondary	Time taken to achieve anti-FXa of =0.2 IU/mL		14 days post hospital admission
Secondary	Number of enoxaparin dose escalations		from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Secondary	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)
Secondary	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)
Secondary	Number of hospital free days		from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Secondary	Number of Ventilator free days		from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Secondary	Number of ICU free days		from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Secondary	Level of Anti-FXa		from the time of hospital admission up to hospital day 7
Secondary	Antithrombin (AT) activity level		from the time of hospital admission up to hospital day 7
Secondary	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
Secondary	Change in level of the endothelial marker thrombomodulin as assessed by a blood test		From the time of hospital admission to day 7
Secondary	Change in level of Inflammatory marker Tumor necrosis factor alpha (TNFa) as assessed by a blood test		From time of hospital admission to day 7
Secondary	Change in level of Inflammatory marker Interleukin-8 (IL-8) as assessed by a blood test		From time of hospital admission to day 7
Secondary	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
Secondary	Change in level of Inflammatory marker Interleukin-1 beta (IL1b) as assessed by a blood test		From time of hospital admission to day 7
Secondary	Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test		From time of hospital admission to day 7
Secondary	Change in level of Inflammatory marker Interferon -gamma (INFg) as assessed by a blood test		From time of hospital admission to day 7
Secondary	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)