Anemia Clinical Trial
Official title:
Use of Combined Tranexamic Acid and Intravenous Iron for Hip Fracture Surgery in Elderly
It is a prospective randomized controlled study aiming to test if tranexamic acid combined to intravenous iron before and after surgery for hip fracture in elderly can decrease peri-operative red cell transfusion.
Hip fracture is an increasing problem. Anemia is a common finding in these patients with a
prevalence ranging from 24% to 44% and is a strong negative prognostic marker. Several
studies have explored whether interventions to improve anemia result in better outcomes.
Thus, alternatives to allogenic red cell transfusion have been suggested in hip fracture,
such as IV iron and tranexamic acid.
The aim of the study is to test the effect of combination of IV iron with tranexamic acid
before and after surgery for hip fracture on incidence of peri-operative red cell
transfusion.
It is a prospective randomized single-blinded monocentric study including 150 patients
undergoing hip fracture surgery within 72 h after trauma aged ≥ 60 years divided in 3
groups: Group A (IV fer+Tranexamic acid), Group B (Tranexamic acid), Group C (placebo). The
main outcome was percentage of patients who receive red-cell transfusion during
hospitalization. Hemoglobin levels up to 60 days post-operatively and incidence of
thrombotic events were secondary outcomes.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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