Phase 4
Completed N=103
Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients
Source: ClinicalTrials.gov NCT02412982 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Initial AT-III Activity -- Control Group vs. Intervention Group Prior to Randomization — 87; 82 Percent AT-III activity (%) — p=0.092
◆ Published Evidence
Emerging
8citations · ~2 / year
Impact of antithrombin III and enoxaparin dosage adjustment on prophylactic anti-Xa concentrations in trauma patients at high risk for venous thromboembolism: a randomized pilot trial.
Summary
This is a pilot study to determine if anti-thrombin III (AT-III) serum concentrations differ between patients with normal versus subtherapeutic anti-Xa trough concentrations when placed on enoxaparin 30 mg twice daily for VTE prophylaxis. Secondarily, this study will compare two enoxaparin dosing strategies.
Linked Publications
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Impact of antithrombin III and enoxaparin dosage adjustment on prophylactic anti-Xa concentrations in trauma patients at high risk for venous thromboembolism: a randomized pilot trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Initial AT-III Activity -- Control Group vs. Intervention Group Prior to Randomization |
87; 82 | 0.092 |
Eligibility Criteria
Inclusion Criteria
- Multi-system trauma
- Anticipated length of stay of at least 72 hours
- At high risk (risk adjustment profile [RAP] >= 5) and initiated on enoxaparin 30 mg every 12 hours per VTE prophylaxis protocol
- No counterindication to trauma team VTE prophylaxis protocol (e.g., intracranial bleeding, incomplete spinal cord injury with hematoma within 24 hours post injury, ongoing hemorrhage, uncorrected coagulopathy, >= grade IV liver or spleen injury, intraocular injury)
Exclusion Criteria
- Renal dysfunction (creatinine clearance 150 kg
- Platelet count 6.6 mg/dL)
- Pregnancy
- Incarceration
Data sourced from ClinicalTrials.gov (NCT02412982) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.