Aspirin versus low-molecular-weight heparin for venous thromboembolism prophylaxis in orthopaedic trauma patients: A patient-centered randomized controlled trial
AuthorHaac, Bryce E
O'Hara, Nathan N
Manson, Theodore T
Slobogean, Gerard P
Castillo, Renan C
O'Toole, Robert V
Stein, Deborah M
PublisherPublic Library of Science
MetadataShow full item record
AbstractBACKGROUND: Emerging evidence suggests aspirin may be an effective venous thromboembolism (VTE) prophylaxis for orthopaedic trauma patients, with fewer bleeding complications. We used a patient-centered weighted composite outcome to globally evaluate aspirin versus low-molecular-weight heparin (LMWH) for VTE prevention in fracture patients. METHODS: We conducted an open-label randomized clinical trial of adult patients admitted to an academic trauma center with an operative extremity fracture, or a pelvis or acetabular fracture. Patients were randomized to receive LMWH (enoxaparin 30-mg) twice daily (n = 164) or aspirin 81-mg twice daily (n = 165). The primary outcome was a composite endpoint of bleeding complications, deep surgical site infection, deep vein thrombosis, pulmonary embolism, and death within 90 days of injury. A Global Rank test and weighted time to event analysis were used to determine the probability of treatment superiority for LMWH, given a 9% patient preference margin for oral administration over skin injections. RESULTS: Overall, 18 different combinations of outcomes were experienced by patients in the study. Ninety-nine patients in the aspirin group (59.9%) and 98 patients in the LMWH group (59.4%) were event-free within 90 days of injury. Using a Global Rank test, the LMWH had a 50.4% (95% CI, 47.7-53.2%, p = 0.73) probability of treatment superiority over aspirin. In the time to event analysis, LMWH had a 60.5% probability of treatment superiority over aspirin with considerable uncertainty (95% CI, 24.3-88.0%, p = 0.59). CONCLUSION: The findings of the Global Rank test suggest no evidence of superiority between LMWH or aspirin for VTE prevention in fracture patients. LMWH demonstrated a 60.5% VTE prevention benefit in the weighted time to event analysis. However, this difference did not reach statistical significance and was similar to the elicited patient preferences for aspirin.
Heparin, Low-Molecular-Weight--therapeutic use
Venous Thromboembolism--prevention & control
Identifier to cite or link to this itemhttp://hdl.handle.net/10713/13542
- Post-discharge adherence with venous thromboembolism prophylaxis after orthopedic trauma: Results from a randomized controlled trial of aspirin versus low molecular weight heparin.
- Authors: Haac BE, Van Besien R, O'Hara NN, Slobogean GP, Manson TT, O'Toole RV, Johal H, Berger PZ, Reahl GB, Marinos D, Degani Y, Mascarenhas D, Connelly D, Scalea TM, Stein DM
- Issue date: 2018 Apr
- 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.
- Authors: O'Toole RV, Stein DM, Frey KP, O'Hara NN, Scharfstein DO, Slobogean GP, Taylor TJ, Haac BE, Carlini AR, Manson TT, Sudini K, Mullins CD, Wegener ST, Firoozabadi R, Haut ER, Bosse MJ, Seymour RB, Holden MB, Gitajn IL, Goldhaber SZ, Eastman AL, Jurkovich GJ, Vallier HA, Gary JL, Kleweno CP, Cuschieri J, Marvel D, Castillo RC, METRC
- Issue date: 2021 Mar 24
- Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis after a Fracture.
- Authors: Major Extremity Trauma Research Consortium (METRC), O'Toole RV, Stein DM, O'Hara NN, Frey KP, Taylor TJ, Scharfstein DO, Carlini AR, Sudini K, Degani Y, Slobogean GP, Haut ER, Obremskey W, Firoozabadi R, Bosse MJ, Goldhaber SZ, Marvel D, Castillo RC
- Issue date: 2023 Jan 19
- Low-molecular-weight heparin is more effective than aspirin in preventing early neurologic deterioration and improving six-month outcome.
- Authors: Yi X, Lin J, Wang C, Zhang B, Chi W
- Issue date: 2014 Jul
- Mobile Compression Reduces Bleeding-related Readmissions and Wound Complications After THA and TKA.
- Authors: Arsoy D, Giori NJ, Woolson ST
- Issue date: 2018 Feb