PREVENTion of Clot in Orthopaedic Trauma

Completed · Phase 3

Conditions studied: Blood Clot, Trauma

In brief

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.

Key facts

Study ID

NCT02984384

Run by

Major Extremity Trauma Research Consortium

People needed

12424

Starts

2017-04-24

Expected to finish

2022-02-18

Last updated by the study team

2024-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Arizona — Tucson, Arizona, United States
• 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
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• 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
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• San Antonio Military Medical Center — San Antonio, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Harborview Medical Center — Seattle, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States
• University of Calgary, Foothills Medical Centre — Calgary, Alberta, Canada
• McMaster University, Hamilton General Hospital — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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