PREVENTion of Clot in Orthopaedic Trauma

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Major Extremity Trauma Research Consortium
• Collaborator: Patient-Centered Outcomes Research Institute
• Treatments: Aspirin; Calcium heparin; Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

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.

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

• 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.