RT Journal Article
SR Electronic
T1 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
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e041845
DO 10.1136/bmjopen-2020-041845
VO 11
IS 3
A1 Robert V O'Toole
A1 Deborah M Stein
A1 Katherine P Frey
A1 Nathan N O'Hara
A1 Daniel O Scharfstein
A1 Gerard P Slobogean
A1 Tara J Taylor
A1 Bryce E Haac
A1 Anthony R Carlini
A1 Theodore T Manson
A1 Kuladeep Sudini
A1 C Daniel Mullins
A1 Stephen T Wegener
A1 Reza Firoozabadi
A1 Elliott R Haut
A1 Michael J Bosse
A1 Rachel B Seymour
A1 Martha B Holden
A1 Ida Leah Gitajn
A1 Samuel Z Goldhaber
A1 Alexander L Eastman
A1 Gregory J Jurkovich
A1 Heather A Vallier
A1 Joshua L Gary
A1 Conor P Kleweno
A1 Joseph Cuschieri
A1 Debra Marvel
A1 Renan C Castillo
A1 ,
YR 2021
UL http://bmjopen.bmj.com/content/11/3/e041845.abstract
AB 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.