Phase 4
N=103
Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients
Traumatic Injury · Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT02412982 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Initial AT-III Activity -- Control Group vs. Intervention Group Prior to Randomization — 87; 82 Percent AT-III activity (%) — p=0.092
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Enoxaparin 40 mg q12h (Drug); Enoxaparin 30 mg q8h (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Initial AT-III Activity -- Control Group vs. Intervention Group Prior to Randomization |
87; 82 | 0.092 |
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.
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). 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.