PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients

Abstract

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.

The effect of calf muscular vein thrombosis on the prognosis within one year postoperatively of geriatric hip fracture patients: a propensity score-matched analysis

“…Currently, there are no long-term follow-up studies of clinical differences between geriatric hip fracture patients with and without CMVT. The clinical relevance of CMVT to the prognosis of geriatric hip fracture patients undergoing surgical treatment remains controversial [16,17]. DVT or PE is one of the most serious complications that can occur in hip fracture patients, signi cantly increasing perioperative mortality [18].…”

Clinical effectiveness and safety of aspirin and other anticoagulants for venous thromboembolism prophylaxis after major orthopedic surgery: a systematic review and meta-analysis of randomized clinical trials

“…The results gave us more insight regarding the need for thromboprophylaxis in trauma patients even though the strength of evidence was not high ( 33 ). The ongoing PREVENT CLOT trial might present more robust data regarding the effectiveness and safety of aspirin compared to that of other anticoagulants as thromboprophylactic agents among trauma patients ( 34 ).…”

Recommendations from the ICM-VTE: Trauma

“…However, we recommend against post-discharge primary thromboprophylaxis unless there are additional major risk factors (such as previous VTE or active cancer); this approach has not been carefully studied and, therefore, is at the clinical judgement of the care team 83 . Further studies are underway 84 .…”

“…However, we recommend against post-discharge primary thromboprophylaxis unless there are additional major risk factors (such as previous VTE or active cancer); this approach has not been carefully studied and, therefore, is at the clinical judgement of the care team 83 . Further studies are underway 84 .We recommend the use of standardized VTE prophylaxis policies, embedded in routine order sets, as well as periodic audits of adherence to reduce unnecessary variability in practice and improve patient outcomes including VTE 37,38,85,86 .…”