IV Iron in Association With Tranexamic Acid for Hip Fracture

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.

Inclusion Criteria:

• Patients undergoing hip fracture surgery within 72 h after trauma.

Exclusion Criteria:

• Vascular events within the last 2 months such as cerebrovascular accident (CVA), Myocardial infarction (MI), Venous Thromboembolism (VTE) and/or recurrent VTE or arterial thrombosis.
• Patients receiving anticoagulation therapy with warfarin or clopidogrel.
• History of seizures.
• Multiple fractures.
• Transfusion received during admission, prior to surgery (Hb< 8g/dl).
• Creatinine clearance less than 30 mL/min
• Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
• Coronary stent placement within the previous 6 months
• Disseminated intravascular coagulation
• Subarachnoid hemorrhage
• Allergy for tranexamic acid
• Hypersensitivity to Iron sucrose or any component of the formulation
• Clinical signs of acute thromboembolic event
• Malignancy
• Body weight > 100kg
• Advanced Dementia