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

April 19, 2024 updated by: Bryan Cotton, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

314

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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.
Experimental: Thrombate infusion
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with incidences of venous thromboembolism (VTE )
Time Frame: 14 days post hospital admission
14 days post hospital admission
Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU/mL
Time Frame: 14 days post hospital admission
14 days post hospital admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Time taken to achieve anti-FXa of ≥0.2 IU/mL
Time Frame: 14 days post hospital admission
14 days post hospital admission
Number of enoxaparin dose escalations
Time Frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
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)
Time Frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
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)
Time Frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Number of hospital free days
Time Frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Number of Ventilator free days
Time Frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Number of ICU free days
Time Frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Level of Anti-FXa
Time Frame: from the time of hospital admission up to hospital day 7
from the time of hospital admission up to hospital day 7
Antithrombin (AT) activity level
Time Frame: from the time of hospital admission up to hospital day 7
from the time of hospital admission up to hospital day 7
Change in level of the endothelial marker syndecan-1 as assessed by a blood test
Time Frame: time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7
time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7
Change in level of the endothelial marker thrombomodulin as assessed by a blood test
Time Frame: From the time of hospital admission to day 7
From the time of hospital admission to day 7
Change in level of Inflammatory marker Tumor necrosis factor alpha (TNFα) as assessed by a blood test
Time Frame: From time of hospital admission to day 7
From time of hospital admission to day 7
Change in level of Inflammatory marker Interleukin-8 (IL-8) as assessed by a blood test
Time Frame: From time of hospital admission to day 7
From time of hospital admission to day 7
Change in level of Inflammatory marker Interleukin-6(IL-6) as assessed by a blood test
Time Frame: time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7
time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7
Change in level of Inflammatory marker Interleukin-1 beta (IL1b) as assessed by a blood test
Time Frame: From time of hospital admission to day 7
From time of hospital admission to day 7
Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test
Time Frame: From time of hospital admission to day 7
From time of hospital admission to day 7
Change in level of Inflammatory marker Interferon -gamma (INFg) as assessed by a blood test
Time Frame: From time of hospital admission to day 7
From time of hospital admission to day 7
Number of participants with In-hospital mortality
Time Frame: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Grifols Shared Services North America, Ind.

Investigators

  • Principal Investigator: Bryan A Cotton, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-22-1102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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