PREVENTion of Clot in Orthopaedic Trauma

  • STATUS
    Recruiting
  • End date
    Feb 4, 2022
  • participants needed
    12200
  • sponsor
    Major Extremity Trauma Research Consortium
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Updated on 4 February 2021
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heparin
aspirin
clot
anticoagulants
enoxaparin
injuries
blood clot

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.

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.

Details
Condition Trauma, Wounds - qualifier, Thrombosis, Blood Clots, Wounds, traumatic injury, traumatic disorder, clot, blood clot, blood clotting
Treatment Acetylsalicylic acid, Low Molecular Weight Heparin (LMWH)
Clinical Study IdentifierNCT02984384
SponsorMajor Extremity Trauma Research Consortium
Last Modified on4 February 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Wounds - qualifier or Trauma or Thrombosis?
Do you have any of these conditions: traumatic disorder or Blood Clots or Thrombosis or Wounds or Trauma or Wounds - qualifier or clot or blood clot or traumatic injury or blood clotting?
Do you have any of these conditions: Trauma or traumatic disorder or traumatic injury or Wounds or Wounds - qualifier or clot or blood clotting or Thrombosis or blood clot or Blood Clots?
Patients who have a planned operative or non-operative pelvis or acetabular
fracture, or any operative extremity fracture proximal to the metatarsals or
carpals

Exclusion Criteria

Patients who present to the hospital more than 48 hours post injury
Patients on long term blood thinners (other than low-dose aspirin or platelet inhibitors such as Plavix or Aggrenox)
Patients who received more than 2 doses of LMWH or aspirin for initial VTE prophylaxis
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
Patients contraindicated for any reason for either medicine
Prisoners
Patients who do not speak either English or Spanish
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
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