PREVENTion of Clot in Orthopaedic Trauma

Study Overview
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Brief Summary
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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
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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.

Official Title
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PREVENTion of Clot in Orthopaedic Trauma (PREVENT CLOT): A Randomized Pragmatic Trial Comparing the Complications and Safety of Blood Clot Prevention Medicines Used in Orthopaedic Trauma Patients

Conditions
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Blood Clot, Trauma

Intervention / Treatment
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* Drug: Acetylsalicylic acid
* Drug: Low Molecular Weight Heparin (LMWH)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Molecular Weight Heparin (LMWH)-Enoxaparin<br>Injection of 30 mg enoxaparin, twice a day via injection | Drug: Low Molecular Weight Heparin (LMWH)<br>* 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.<br>* Other names: Enoxaparin;|
| Active Comparator: Acetylsalicylic acid (ASA)-Aspirin<br>Enteral ingestion or administration of 81 mg ASA, twice a day | Drug: Acetylsalicylic acid<br>* The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.<br>* Other names: Aspirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cause-specific death |  | 90 days | 
| Non-fatal pulmonary embolism |  | 90 days | 
| Deep vein thrombosis |  | 90 days | 
| Bleeding complication |  | 90 days | 
| Wound complication |  | 90 days | 
| Deep surgical site infection |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma, Blood clot, Venous Thromboembolism, Pulmonary Embolism, Deep Vein Thrombosis, Thromboprophylaxis, Blood clot prevention, trauma patients