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| Name | Class |
|---|---|
| Grifols Shared Services North America, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thrombate infusion | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombate infusion | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with incidences of venous thromboembolism (VTE ) | 14 days post hospital admission | |
| Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU/mL | 14 days post hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| Time taken to achieve anti-FXa of ≥0.2 IU/mL | 14 days post hospital admission | |
| Number of enoxaparin dose escalations | from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan A Cotton, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States | ||
| Jackson Memorial Hospital/University of Miami |
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Multi-center, placebo-controlled, randomized, double-blind study
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This will be a double-blind study.
| Placebo | Drug | Normal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight. |
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| Number of incidences of participants with other thrombotic complications (arterial thrombosis, myocardial infarction, stroke) | 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) | from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first) |
| Number of hospital free days | from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first) |
| Number of Ventilator free days | from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first) |
| Number of ICU free days | from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first) |
| Level of Anti-FXa | from the time of hospital admission up to hospital day 7 |
| Antithrombin (AT) activity level | 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 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 | 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 | From time of hospital admission to day 7 |
| Change in level of Inflammatory marker Interleukin-8 (IL-8) as assessed by a blood test | 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 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 | From time of hospital admission to day 7 |
| Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test | From time of hospital admission to day 7 |
| Change in level of Inflammatory marker Interferon -gamma (INFg) as assessed by a blood test | From time of hospital admission to day 7 |
| Number of participants with In-hospital mortality | from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first) |
| Miami |
| Florida |
| 33136 |
| United States |
| Vanderbilt University Hospital | Nashville | Tennessee | 37212 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D000081084 | Accidental Injuries |
| D013923 | Thromboembolism |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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