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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism (TRAIT)
- ClinicalTrials.gov ID
- NCT05794165
- Acronym / sponsor ID
- TRAIT / HSC-MS-22-1102
- Conditions
- Trauma Injury, Thromboembolism, Venous Thromboembolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Bryan CottonUniversity, hospital or other
- Collaborators
- Grifols Shared Services North America, Inc.
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center, placebo-controlled, randomized, double-blind study
| Arm | Type | Receives |
|---|---|---|
| Thrombate infusion | Experimental | Drug: Thrombate infusion |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombate infusionBolus 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. | Drug | Thrombate infusion |
| PlaceboNormal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight. | Drug | Placebo |
Primary outcome
Number of participants with incidences of venous thromboembolism (VTE )
Time frame: 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
18 secondary outcomes
Time taken to achieve anti-FXa of ≥0.2 IU/mL
Time frame: 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)
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)
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)
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)
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)
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)
Level of Anti-FXa
Time frame: 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
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
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
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
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
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
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
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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bryan A Cotton, MD principal investigator
The University of Texas Health Science Center, Houston
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thrombate infusion in people with Trauma Injury and Thromboembolism, run by Bryan Cotton at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with incidences of venous thromboembolism (VTE ) (time frame: 14 days post hospital admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.