In:
BMJ Open, BMJ, Vol. 11, No. 3 ( 2021-03), p. e041845-
Abstract:
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 .
Type of Medium:
Online Resource
ISSN:
2044-6055
,
2044-6055
DOI:
10.1136/bmjopen-2020-041845
Language:
English
Publisher:
BMJ
Publication Date:
2021
detail.hit.zdb_id:
2599832-8
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