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

NCT05794165 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: HSC-MS-22-1102
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 4

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.

Conditions

Trauma Injury; Thromboembolism; Venous Thromboembolism

Outcome Measures

Primary Outcomes (2)

• Number of participants with incidences of venous thromboembolism (VTE )

  14 days post hospital admission

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

  14 days post hospital admission

Secondary Outcomes (18)

• 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)

• 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)

Study Arms (2)

Thrombate infusion

EXPERIMENTAL

Drug: Thrombate infusion

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Thrombate infusion DRUG

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.

Thrombate infusion

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bryan Cotton: lead
• Grifols Shared Services North America, Ind.: collaborator

Study Sites (4)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Jackson Memorial Hospital/University of Miami

Miami, Florida, 33136, United States

Location

Vanderbilt University Hospital

Nashville, Tennessee, 37212, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Accidental Injuries; Thromboembolism; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Wounds and Injuries; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bryan A Cotton, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Multi-center, placebo-controlled, randomized, double-blind study

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 3, 2023
• Study Start: September 27, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)