#3001 The effect of prophylactic anticoagulation on major bleeding events in hospitalized chronic kidney disease and lower limb fracture patients. A phase 2, randomized, double blind, control trial

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Abstract Background and Aims People with advanced chronic kidney disease (CKD) have an increased risk of lower limb fractures. During hospitalization with this event the risk of thrombosis increases so prophylactic anticoagulation is recommended. The risk of bleeding may be greater than the benefit of antithrombotic protection in this population. We aimed to assess if enoxaparin (anticoagulation) or placebo (no anticoagulation) are different in the occurrence of major bleeding and thrombosis. Method In a phase 2 randomized controlled trial, from March 2019 to October 2024, patients with lower limb fracture and advanced CKD were eligible. We randomly assigned 61 patients to the placebo (n = 30) and anticoagulation groups (enoxaparin 40 mg; n = 31). Primary outcome was the risk of major bleeding. The main secondary objectives were risk of thrombosis, death, number of transfusions, dialysis requirement, hospitalization days, and the adverse events (AEs) related to anticoagulation. Results Both groups were similar, mean (SD) age of 65 (19) years; 54% were women, the eGFR of 24 ml/min/1.73 m2. Hip fracture predominate (45.9%), followed by femur and tibia (31.1% and 23%, respectively). The primary outcome major bleeding occurred in 5 (16.1%) in the enoxaparin group and 4 (13.3%) in the placebo group. After adjusted analysis, comparing the enoxaparin with the placebo group, no increase in the risk of bleeding was observed (OR 1.28, CI 0.29–6.06, P = 0.741), nor was stratifying by CKD stages (P = >0.05). The frequency of thrombosis in 2 (6.7%) patients in the placebo and 1 (3.2%) in the enoxaparin group, with no difference between groups (P = 0.61). Hospitalization days were fewer in the placebo group compared to the enoxaparin group (14 vs 19, P = 0.023), reducing the hospital stay by 5.3 days (OR 5.31, 95% CI -10.52- -0.09, P = 0.046). AEs attributed to the intervention, gastrointestinal bleeding occurred in 2 and 1 patient in the placebo and enoxaparin groups, respectively. Conclusion In patients with advanced CKD and lower limb fracture, prophylactic anticoagulation with enoxaparin, compared with no anticoagulation, did not promote more major bleeding or prevent DVT, but prolong hospitalization by 5 days.

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