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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Bryan Cotton
Study ID
NCT05794165
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Thromboembolism
  • Trauma Injury
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 27, 2023
Status verified
May 2025
Primary completion
Nov 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
314 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Thrombate infusion
  • Placebo Comparator: Placebo

Primary Outcome Measure

Number of participants with incidences of venous thromboembolism (VTE ) [ Time Frame: 14 days post hospital admission ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045-
Jackson Memorial Hospital/University of MiamiMiamiFlorida33136-
Vanderbilt University HospitalNashvilleTennessee37212-
The University of Texas Health Science Center at HoustonHoustonTexas77030-

Find similar trials in Aurora, CO

By research site
University of Colorado· Aurora, COJackson Memorial Hospital/University of Miami· Miami, FLVanderbilt University Hospital· Nashville, TNThe University of Texas Health Science Center at Houston· Houston, TX

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