Phase 3
N=12,424
PREVENTion of Clot in Orthopaedic Trauma
Blood Clot · Trauma
Bottom Line
View on ClinicalTrials.gov: NCT02984384 ↗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
| Outcome | Result | p-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
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.