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

Primary Purpose

Trauma Injury, Thromboembolism, Venous Thromboembolism

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thrombate infusion
Placebo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Thrombate infusion

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with incidences of venous thromboembolism (VTE )
Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU/mL

Secondary Outcome Measures

Time taken to achieve anti-FXa of ≥0.2 IU/mL
Number of enoxaparin dose escalations
Number of incidences of participants with other thrombotic complications (arterial thrombosis, myocardial infarction, stroke)
Number of incidences of participants with bleeding events (interoperative bleeding, abdominal bleeding)
Number of hospital free days
Number of Ventilator free days
Number of ICU free days
Level of Anti-FXa
Antithrombin (AT) activity level
Change in level of the endothelial marker syndecan-1 as assessed by a blood test
Change in level of the endothelial marker thrombomodulin as assessed by a blood test
Change in level of Inflammatory marker Tumor necrosis factor alpha (TNFα) as assessed by a blood test
Change in level of Inflammatory marker Interleukin-8 (IL-8) as assessed by a blood test
Change in level of Inflammatory marker Interleukin-6(IL-6) as assessed by a blood test
Change in level of Inflammatory marker Interleukin-1 beta (IL1b) as assessed by a blood test
Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test
Change in level of Inflammatory marker Interferon -gamma (INFg) as assessed by a blood test
Number of participants with In-hospital mortality

Full Information

First Posted
March 14, 2023
Last Updated
September 6, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Grifols Shared Services North America, Ind.
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1. Study Identification

Unique Protocol Identification Number
NCT05794165
Brief Title
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
Acronym
TRAIT
Official Title
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism (TRAIT)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Grifols Shared Services North America, Ind.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma Injury, Thromboembolism, Venous Thromboembolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multi-center, placebo-controlled, randomized, double-blind study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This will be a double-blind study.
Allocation
Randomized
Enrollment
314 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thrombate infusion
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Thrombate infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal Saline will be given as one time IV after the 3rd dose of Enoxaparin. The dose will be based on patient weight.
Primary Outcome Measure Information:
Title
Number of participants with incidences of venous thromboembolism (VTE )
Time Frame
14 days post hospital admission
Title
Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU/mL
Time Frame
14 days post hospital admission
Secondary Outcome Measure Information:
Title
Time taken to achieve anti-FXa of ≥0.2 IU/mL
Time Frame
14 days post hospital admission
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Level of Anti-FXa
Time Frame
from the time of hospital admission up to hospital day 7
Title
Antithrombin (AT) activity level
Time Frame
from the time of hospital admission up to hospital day 7
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan A Cotton, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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