Overview

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

Status:
Not yet recruiting
Trial end date:
2026-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborator:
Grifols Therapeutics LLC
Criteria
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