Phase 3
N=329
A Different Approach to Preventing Thrombosis
Venous Thromboembolism · Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT02774265 ↗Enrolled (actual)
329
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication. — 52; 53 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- VTE prophylaxis with Enoxaparin 30mg BID (Drug); VTE prophylaxis with Aspirin 81mg BID (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication. |
52; 53 | — |
| SECONDARY Number of Participants With Deep Venous Thromboembolism |
5; 9 | — |
| SECONDARY Number of Participants With Pulmonary Embolism Events |
6; 2 | — |
Summary
The purpose of this study is to perform a pragmatic randomized controlled trial to compare the use of low molecular weight heparin (LMWH, lovenox, enoxaparin) versus acetylsalicylic acid (ASA) for venous thromboembolism (VTE) prophylaxis in patients with high-risk lower extremity fractures.
Eligibility Criteria
Inclusion Criteria
- All patients treated at a level-1 trauma center with any one or more of the following injuries: Pelvis fracture (operative or non-operative), Acetabulum fracture (operative or non-operative), or any operative extremity fracture (proximal to metatarsals/carpals)
- Age greater than or equal to 18 years old
Exclusion Criteria
- Patients receiving pre-existing confounding prophylaxis or therapeutic anticoagulation (not to include anti-platelet agents) prior to admission or those receiving greater than one dose of LMWH since injury
- Patients with pre-existing coagulopathy
- Patients with a previous history of VTE within the last 6 months
- Patients who are pregnant
- Patients with CNS or spinal cord injury with potential need for further neurosurgical intervention precluding anticoagulation with aspirin
- Patients with active bleeding precluding the use of anticoagulation
- Impaired creatinine clearance <30ml/min at the time of randomization
- History of Heparin Induced Thrombocytopenia or ASA or NSAID allergy
- Prisoners
- Non-english speaking patients
- Patients who have an indication for therapeutic anticoagulation
- Patients deemed inappropriate for inclusion in the study by their treating physician. Reason must be documented
- Patients who would not normally receive VTE prophylaxis for their injury
Data sourced from ClinicalTrials.gov (NCT02774265). 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.