PREVENTion of Clot in Orthopaedic Trauma

Phase 3

Completed

Conditions: Blood Clot
Trauma

Interventions: Drug: Low Molecular Weight Heparin (LMWH)
Drug: Acetylsalicylic acid

Registration Number: NCT02984384

Lead Sponsor: Major Extremity Trauma Research Consortium

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12424

Inclusion Criteria

Patients who have a planned operative or non-operative pelvis or acetabular fracture, or any operative extremity fracture proximal to the metatarsals or carpals.
Patients at increased risk of blood clot(s) from their orthopaedic injury(ies) and will receive prophylactic blood thinner regimen per standard of care.
Patients 18 years or older.

Exclusion Criteria

Patients who present to the hospital more than 48 hours post injury
Patients who received more than 2 doses of LMWH or aspirin for initial VTE prophylaxis
Patients on long term blood thinners (other than low-dose aspirin or platelet inhibitors such as Plavix or Aggrenox)
Patients who have had a VTE within the last 6 months
Patients on therapeutic (as opposed to prophylactic) blood thinners for an acute issue at the time of admission
Patients who have a newly diagnosed indication for therapeutic blood thinners (for example vascular injury) that will require therapeutic anticoagulation for more than one week
Patients who cannot receive either of the study medications due to an allergy (history of heparin induced thrombocytopenia, allergy to aspirin, or NSAIDs) or other medical contraindication to blood thinners
Patients who are on higher dose aspirin (>81 mg once a day or higher) for medical reasons or who will be treated with higher dose aspirin
Patients with underlying chronic clotting disorders (i.e. Factor V Leiden, hyperhomocysteinemia, Protein C and S deficiency) that require full dose anticoagulation or are a contraindication to venous thromboembolism chemoprophylaxis
Patients with end stage renal disease or impaired creatinine clearance <30 ml/min at time of randomization(note: creatinine clearance does not need to be documented if prescribing physician would order medication without test as SOC)
Pregnant or lactating patients
Prisoners
Patients who do not speak either English or Spanish
Patients who are likely to have severe problems maintaining follow-up
Patients, based upon the clinical judgment of the treating clinician, NOT equally suited for treatment with either aspirin or low-molecular-weight heparin
Patients may be excluded for other reasons at the discretion of the treating physician; the reason for exclusion must be documented on the screening form
Patients who have a known COVID-19 diagnosis prior to fracture treatment or within 3 months of the index fracture

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Molecular Weight Heparin (LMWH)-Enoxaparin	Low Molecular Weight Heparin (LMWH)	Injection of 30 mg enoxaparin, twice a day via injection
Acetylsalicylic acid (ASA)-Aspirin	Acetylsalicylic acid	Enteral ingestion or administration of 81 mg ASA, twice a day

Primary Outcome Measures

Name	Time	Method
Number of Participants With All-cause Mortality	90 days	Death from any cause

Secondary Outcome Measures

Name	Time	Method
Deep Vein Thrombosis	90 days
Bleeding Complication	90 days
Wound Complication	90 days
Number of Participants With Cause-specific Death	90 days	Cause specific death. Some participants are reported twice if reason for death met more than one category.
Non-fatal Pulmonary Embolism	90 days
Deep Surgical Site Infection	90 days

Trial Locations

Locations (21): Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University of Arizona
🇺🇸
Tucson, Arizona, United States
MetroHealth Medical Center
🇺🇸
Cleveland, Ohio, United States
University of Miami Ryder Trauma Center
🇺🇸
Miami, Florida, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Maryland R Adams Cowley Shock Trauma Center
🇺🇸
Baltimore, Maryland, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
University of Mississippi Medical Center
🇺🇸
Jackson, Mississippi, United States
Harborview Medical Center
🇺🇸
Seattle, Washington, United States
University of Calgary, Foothills Medical Centre
🇨🇦
Calgary, Alberta, Canada
Rhode Island Hospital, Brown University
🇺🇸
Providence, Rhode Island, United States
University of Tennessee, RegionOne Medical Center
🇺🇸
Memphis, Tennessee, United States
Vanderbilt Medical Center
🇺🇸
Nashville, Tennessee, United States
Inova Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
University of Wisconsin
🇺🇸
Madison, Wisconsin, United States
McMaster University, Hamilton General Hospital
🇨🇦
Hamilton, Ontario, Canada
Methodist Hospital
🇺🇸
Indianapolis, Indiana, United States
Wake Forest University Baptist Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
University of Texas Health Science Center at Houston
🇺🇸
Houston, Texas, United States
San Antonio Military Medical Center
🇺🇸
San Antonio, Texas, United States
Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States