Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
12424 participants
INTERVENTIONAL
2017-04-24
2022-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Low Molecular Weight Heparin (LMWH)-Enoxaparin
Injection of 30 mg enoxaparin, twice a day via injection
Low Molecular Weight Heparin (LMWH)
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.
Acetylsalicylic acid (ASA)-Aspirin
Enteral ingestion or administration of 81 mg ASA, twice a day
Acetylsalicylic acid
The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.
Interventions
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Acetylsalicylic acid
The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.
Low Molecular Weight Heparin (LMWH)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Major Extremity Trauma Research Consortium
OTHER
Responsible Party
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Principal Investigators
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Robert O'Toole, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland
Renan Castillo, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Tara Taylor, MPH
Role: STUDY_DIRECTOR
Johns Hopkins Bloomberg School of Public Health
Katherine Frey, PhD, MPH, RN
Role: STUDY_DIRECTOR
Johns Hopkins Bloomberg School of Public Health
Locations
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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
Countries
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References
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O'Toole RV, Stein DM, Frey KP, O'Hara NN, Scharfstein DO, Slobogean GP, Taylor TJ, Haac BE, Carlini AR, Manson TT, Sudini K, Mullins CD, Wegener ST, Firoozabadi R, Haut ER, Bosse MJ, Seymour RB, Holden MB, Gitajn IL, Goldhaber SZ, Eastman AL, Jurkovich GJ, Vallier HA, Gary JL, Kleweno CP, Cuschieri J, Marvel D, Castillo RC; METRC. PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients. BMJ Open. 2021 Mar 24;11(3):e041845. doi: 10.1136/bmjopen-2020-041845.
Major Extremity Trauma Research Consortium (METRC); O'Toole RV, Stein DM, O'Hara NN, Frey KP, Taylor TJ, Scharfstein DO, Carlini AR, Sudini K, Degani Y, Slobogean GP, Haut ER, Obremskey W, Firoozabadi R, Bosse MJ, Goldhaber SZ, Marvel D, Castillo RC. Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis after a Fracture. N Engl J Med. 2023 Jan 19;388(3):203-213. doi: 10.1056/NEJMoa2205973.
O'Hara NN, Degani Y, Marvel D, Wells D, Mullins CD, Wegener S, Frey K, Joseph T, Hurst J, Castillo R, O'Toole RV; PREVENT CLOT Stakeholder Committee. Which orthopaedic trauma patients are likely to refuse to participate in a clinical trial? A latent class analysis. BMJ Open. 2019 Oct 11;9(10):e032631. doi: 10.1136/bmjopen-2019-032631.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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PCS-1511-32745
Identifier Type: -
Identifier Source: org_study_id
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