A Phase 2 interventional study of Thrombate infusion and Placebo in Trauma Injury, Thromboembolism and Venous Thromboembolism, sponsored by Bryan Cotton. Enrolling by invitation at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Bryan Cotton · Phase 2, Interventional, and Treatment
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.
128 studies on the registry are indexed under Accidental Injuries; 39 are open to participants now.
This study's planned enrollment of 314 is above the median of 110 across 67 interventional studies indexed under Accidental Injuries.
Browse Accidental Injuries studies →Bryan Cotton is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Thrombate infusion
Drug: Placebo
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.
Normal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight.
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
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)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Bryan Cotton