Department of Orthopaedics, University of Maryland Baltimore, Baltimore, Maryland, USA
Department of Surgery, University of California in San Francisco, San Francisco, California, USA.
BMJ Open. 2021 Mar 24;11(3):e041845. doi: 10.1136/bmjopen-2020-041845.
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.
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.
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.
NCT02984384.
接受骨科创伤治疗的患者发生静脉血栓栓塞症（VTE）的风险增加，包括致命性肺栓塞（PE）。目前的指南建议使用低分子肝素（LMWH）对骨科创伤患者进行 VTE 预防。然而，在全膝关节置换术患者中的新出现的文献表明，阿司匹林预防 VTE 具有潜在的临床益处。本试验的主要目的是比较阿司匹林与 LMWH 作为骨折患者的血栓预防药物。
PREVENT CLOT 是一项多中心、随机、实用的试验，旨在招募 12200 名成年患者，这些患者在 21 个参与中心中的 1 个中心因手术肢体骨折，或任何骨盆或髋臼骨折而入院。主要结局是全因死亡率。我们将通过测试随机分组后 90 天内意向治疗死亡概率在阿司匹林和 LMWH 之间的差异是否小于我们的非劣效性边界 0.75%来评估非劣效性。次要疗效结局包括病因特异性死亡率、非致死性 PE 和深静脉血栓形成。安全性结局包括出血并发症、伤口并发症和深部手术部位感染。
PREVENT CLOT 试验已获得协调中心（约翰霍普金斯布隆伯格公共卫生学院）和所有参与中心的伦理委员会的批准。招募于 2017 年 4 月开始，预计持续到 2021 年。由于两种研究药物目前均用于骨科创伤患者的 VTE 预防，因此本试验的结果可以很容易地应用于临床实践。这项大型、以患者为中心的实用试验的结果将有助于指导治疗选择，以预防骨折患者的 VTE。
NCT02984384。
