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Phase 3 N=12,424 Randomized Single-blind Prevention

PREVENTion of Clot in Orthopaedic Trauma

Blood Clot · Trauma

Enrolled (actual)
12,424
Serious AEs
4.8%
Results posted
May 2024
Primary outcome: Primary: Number of Participants With All-cause Mortality — 45; 47 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Acetylsalicylic acid (Drug); Low Molecular Weight Heparin (LMWH) (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Major Extremity Trauma Research Consortium
Primary completion
Feb 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With All-cause Mortality
45; 47
SECONDARY
Number of Participants With Cause-specific Death
5; 4; 14; 18; 31; 29
SECONDARY
Non-fatal Pulmonary Embolism
90; 90
SECONDARY
Deep Vein Thrombosis
103; 151
SECONDARY
Bleeding Complication
869; 834
SECONDARY
Wound Complication
14; 8
SECONDARY
Deep Surgical Site Infection
93; 103

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.

Eligibility 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.
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02984384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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