NCT05794165

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

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

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Bryan Cotton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma Injury
• Thromboembolism
• Venous Thromboembolism

Interventions

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

Timeline

• Start date: 2023-09-27
• Primary completion: 2026-11-01
• Completion: 2027-03-01
• First posted: 2023-04-03
• Last updated: 2025-05-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study