The purpose of this study is to compare aspirin versus low-molecular weight heparin (LMWH) (Enoxaparin) as a thromboprophylaxis in patients who sustain a fracture.
Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. This trial aims to determine if aspirin is non-inferior to LMWH for thromboprophylaxis in fracture patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
12,424
The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.
The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.
University of Arizona
Tucson, Arizona, United States
Number of Participants With All-cause Mortality
Death from any cause
Time frame: 90 days
Number of Participants With Cause-specific Death
Cause specific death. Some participants are reported twice if reason for death met more than one category.
Time frame: 90 days
Non-fatal Pulmonary Embolism
Time frame: 90 days
Deep Vein Thrombosis
Time frame: 90 days
Bleeding Complication
Time frame: 90 days
Wound Complication
Time frame: 90 days
Deep Surgical Site Infection
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Miami Ryder Trauma Center
Miami, Florida, United States
Methodist Hospital
Indianapolis, Indiana, United States
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
...and 11 more locations