PREVENT CLOT
Trial question
Is thromboprophylaxis with aspirin noninferior to LMWH in patients with extremity fractures that had been treated operatively or with any pelvic or acetabular fracture?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 12211
12211 patients (4610 female, 7601 male)
Inclusion criteria: patients with extremity fractures that had been treated operatively or with any pelvic or acetabular fracture
Key exclusion criteria: presentation to the hospital > 48 hours after injury or receipt of ≥ 3 doses of thromboprophylaxis before enrollment; history of a VTE diagnosis in the past 6 months; receipt of therapeutic anticoagulation at the time of admission; chronic blood-clotting disorder
Interventions
N=6101 aspirin (at a dose of 81 mg BID)
N=6110 LMWH (enoxaparin at a dose of 30 mg BID)
Primary outcome
Death from any cause at day 90
0.78
0.73
0.8 %
0.6 %
0.4 %
0.2 %
0.0 %
Aspirin
LMWH
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in death from any cause at day 90 (0.78% vs. 0.73%; AD 0.05%, 96% CI -0.27 to 0.38)
Secondary outcomes
Significant increase in DVT (2.51% vs. 1.71%; AD 0.8%, 95% CI 0.28 to 1.31)
No significant difference in death related to PE (0.07% vs. 0.08%; ARD -0.02, 95% CI -0.12 to 0.08)
No significant difference in PE (1.49% vs. 1.49%; )
Safety outcomes
No significant differences in bleeding complications, wound complications, infections.
Conclusion
In patients with extremity fractures that had been treated operatively or with any pelvic or acetabular fracture, aspirin was noninferior to LMWH with respect to death from any cause at day 90.
Reference
Major Extremity Trauma Research Consortium (METRC), Robert V O'Toole, Deborah M Stein et al. Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis after a Fracture. N Engl J Med. 2023 Jan 19;388(3):203-213.
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