Tranexamic acid use to reduce de blood transfusion in femur fracture patients. Clinical randomized trial with placebo control

INTERVENTION: Trade Name: Amchafibrin Product Name: Tranexamic acid Pharmaceutical Form: Solution for injection INN or Proposed INN: Tranexamic acid CAS Number: 1197‐18‐8 Current Sponsor code: Tranexamic acid Other descriptive name: TRANEXAMIC ACID PH. EUR. Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 1000‐ Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Intravenous use CONDITION: Bleeding in patients suffering femur neck fracture ; MedDRA version: 20.1 Level: LLT Classification code 10053220 Term: Hip injury System Organ Class: 100000004863 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Surgical Procedures, Operative [E04] PRIMARY OUTCOME: Main Objective: Reduction in the number of patients who need a red blood cell transfusion after femur fracture Primary end point(s): Reduction in the transfusion rate of 30% Secondary Objective: Reduction in the amount of red cell packs transfused in patients with femur fracture; Reduction in the calculated blood losses in patients with femur fracture; Assessment of safety of tranexamic acid in patients with femur fracture Timepoint(s) of evaluation of this end point: 30 days after trauma femur fracture SECONDARY OUTCOME: Secondary end point(s): Reduction in 50% of patients who need more than one red blood cell concentrate Timepoint(s) of evaluation of this end point: 30 days after trauma femur fracture INCLUSION CRITERIA: Age > 64 Femur fracture that needs surgical treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 276