Introduction
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. The primary aim of this trial
is to compare aspirin with LMWH as a thromboprophylaxis in fracture
patients.
Methods and analysis
PREVENT CLOT is a multicentre, randomised, pragmatic trial that aims
to enrol 12 200 adult patients admitted to 1 of 21 participating centres
with an operative extremity fracture, or any pelvis or acetabular
fracture. The primary outcome is all-cause mortality. We will evaluate
non-inferiority by testing whether the intention-to-treat difference in
the probability of dying within 90 days of randomisation between aspirin
and LMWH is less than our non-inferiority margin of 0.75%. Secondary
efficacy outcomes include cause-specific mortality, non-fatal PE and
deep vein thrombosis. Safety outcomes include bleeding complications,
wound complications and deep surgical site infections.
Ethics and dissemination
The PREVENT CLOT trial has been approved by the ethics board at the
coordinating centre (Johns Hopkins Bloomberg School of Public Health)
and all participating sites. Recruitment began in April 2017 and will
continue through 2021. As both study medications are currently in
clinical use for VTE prophylaxis for orthopaedic trauma patients, the
findings of this trial can be easily adopted into clinical practice. The
results of this large, patient-centred pragmatic trial will help guide
treatment choices to prevent VTE in fracture patients.
Trial registration number
NCT02984384.
Aspirin versus low-molecular-weight heparin for venous thromboembolism prophylaxis in orthopaedic trauma patients: A patient-centered randomized controlled trial
