Phase 4
N=495
Venous Thromboembolic Prophylaxis After Trauma: Three Times a Day Unfractionated Heparin Versus Twice a Day Enoxaparin
Venous Thromboembolic Disease · Deep Vein Thrombosis · Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT01729559 ↗Enrolled (actual)
495
Serious AEs
0.9%
Results posted
Jul 2016
Primary outcome: Primary: Lower Extremity Deep Vein Thrombosis — 4.8; 2.9 percentage of patients — p=0.025
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 5000 Units unfractionated Heparin Q 8 hr (Drug); 30mg enoxaparin Q12 hr (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Scripps Health
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lower Extremity Deep Vein Thrombosis |
4.8; 2.9 | 0.025 sig |
| PRIMARY Pulmonary Embolus |
1; 0 | — |
| SECONDARY Bleeding Event |
2; 3 | — |
| SECONDARY Heparin Induced Thrombocytopenia |
1; 0 | — |
Summary
The rate of venous thromboembolic events in trauma patients at high risk for deep vein thrombosis and pulmonary embolism receiving low dose unfractionated heparin every 8 hours will be equivalent or less than a similar group of patients given a standard every 12 hour dose of low molecular weight heparin.
Eligibility Criteria
Inclusion Criteria
- Admitted to Scripps Mercy Trauma Service
- ≥18 Years old
- Stratified to either Significant or Highest risk of VTE by ACCP guidelines
Exclusion Criteria
- Estimated Injury Severity Score (ISS) ≤9
- Likely to be discharged before hospital day 7
- Systemic coagulopathy defined with an International Normalized Ratio (INR) of ≥1.2
- Body Mass Index (BMI) >40
- Likely to Survive for 24 hrs)
- Prisoners
Data sourced from ClinicalTrials.gov (NCT01729559). 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.