A Different Approach to Preventing Thrombosis
Condition: Venous Thromboembolism; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism
Intervention: VTE prophylaxis with Enoxaparin 30mg BID; VTE prophylaxis with Aspirin 81mg BID
Intervention description: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.; Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
Intervention MeSH terms: Aspirin; Heparin; Enoxaparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 329.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fracture; Prophylaxis

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