Trauma InjuryPhase 2TRAITNCT05794165
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
A Phase 2 study testing Thrombate infusion in people with Trauma Injury and Thromboembolism, run by Bryan Cotton at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury, Thromboembolism, Venous Thromboembolism
- What is being tested?
- Thrombate infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Sep 2023to Sep 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
University of Colorado
Aurora, Colorado, 80045
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Jackson Memorial Hospital/University of Miami
Miami, Florida, 33136
Vanderbilt University Hospital
Nashville, Tennessee, 37212
About this study
Official title: 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.
- Conditions
- Trauma Injury, Thromboembolism, Venous Thromboembolism
- Being tested
- Thrombate infusion, Placebo
- Medical subject headings
- Accidental Injuries, Thromboembolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombate infusionDrug
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.
PlaceboDrug
Normal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight.
| Study group | Role | What they receive |
|---|---|---|
| Thrombate infusion | Experimental | Not described Receives: Drug: Thrombate infusion |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with incidences of venous thromboembolism (VTE )
Measured: 14 days post hospital admission
Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU/mL
Measured: 14 days post hospital admission
Secondary outcomes (18)
Time taken to achieve anti-FXa of ≥0.2 IU/mL
Measured: 14 days post hospital admission
Number of enoxaparin dose escalations
Measured: 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)
Measured: 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)
Measured: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Number of hospital free days
Measured: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Number of Ventilator free days
Measured: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Number of ICU free days
Measured: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Level of Anti-FXa
Measured: from the time of hospital admission up to hospital day 7
Antithrombin (AT) activity level
Measured: 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
Measured: 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
Measured: 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
Measured: From time of hospital admission to day 7
Change in level of Inflammatory marker Interleukin-8 (IL-8) as assessed by a blood test
Measured: From time of hospital admission to day 7
Change in level of Inflammatory marker Interleukin-6(IL-6) as assessed by a blood test
Measured: 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
Measured: From time of hospital admission to day 7
Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test
Measured: From time of hospital admission to day 7
Change in level of Inflammatory marker Interferon -gamma (INFg) as assessed by a blood test
Measured: From time of hospital admission to day 7
Number of participants with In-hospital mortality
Measured: from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start27 Sep 2023
- Primary completionApr 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, placebo-controlled, randomized, double-blind study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bryan Cotton
- Sponsor type
- University, hospital or other
- Collaborators
- Grifols Shared Services North America, Inc.
- Responsible party
- Sponsor-investigator, Bryan Cotton, The University of Texas Health Science Center, Houston
- Investigators
- Bryan A Cotton, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794165
- Sponsor's protocol ID
- HSC-MS-22-1102
- Acronym
- TRAIT
- Status last verified
- Oct 2026
- First submitted
- 14 Mar 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No