CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY IN ELDERLY PATIENTS WITH PERTROCHANTERIC FRACTURE, RECEIVING TREATMENT WITH TRANEXAMIC ACID IV VS IV+LOCAL IN THE SURGICAL BED

INTERVENTION: Trade Name: AMCHAFIBRIN Pharmaceutical Form: Solution for injection INN or Proposed INN: Tranexamic acid Other descriptive name: Tranexamic acid Concentration unit: g gram(s) Concentration type: equal Concentration number: 3‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Local use (Noncurrent) CONDITION: pertrochanteric hip fracture ; MedDRA version: 23.0 Level: PT Classification code 10020100 Term: Hip fracture System Organ Class: 10022117 ‐ Injury, poisoning and procedural complications Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: to demonstrate the reduction of blood loss with the use of local tranexamic combined with intravenous tranexamic acid Primary end point(s): reduction of blood loss with the use of local tranexamic combined with intravenous tranexamic acid Secondary Objective: ‐ To corroborate the safety of the local use of tranexamic acid in pertrochanteric hip fractures.; ‐ To evaluate differences in the length of hospital stay. Timepoint(s) of evaluation of this end point: analytical control the day after surgery SECONDARY OUTCOME: Secondary end point(s): safety of the local use of tranexamic acid in pertrochanteric hip fractures.; differences in the length of hospital stay. Timepoint(s) of evaluation of this end point: safety: postoperative period, 4‐6 weeks and 6 months after surgery; Hospital Stay: discharge INCLUSION CRITERIA: Patients with pertrochanteric hip fracture admitted to the Gregorio Marañon Hospital during the study period. Signed written informed consent form. Men and women aged 65 years or older. 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 102