PHASE III, SINGLE-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, LOW-INTERVENTION CLINICAL TRIAL IN TWO PARALLEL GROUPS, TO EVALUATE EFFICACY AND SAFETY IN ELDERLY PATIENTS WITH PERTROCHANTERIC FRACTURE, RECEIVING TREATMENT WITH TRANEXAMIC ACID IV VS. IV+LOCAL IN THE SURGICAL BED.

Coral Sánchez Pérez0 个研究点目标入组 102 人开始时间: 2023年3月24日最近更新: 2023年7月18日

适应症

试验速览

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•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

•Fractures of pathological origin (tumor) and those due to polytrauma (2 or more concomitant fractures due to high-energy trauma) and patients with a previous habitual consumption of anticoagulants or antiplatelet drugs will be excluded. The latter will only be excluded from the preelimination analysis to avoid bias, but will be randomized and taken into account at a later stage.
•The presence in the anamnesis of all the conditions that are a contraindication for the use of the drug, as listed in the drug's technical data sheet, will be considered exclusion criteria:
•Acute arterial or venous thrombosis.
•Fibrinolytic diseases after consumption coagulopathy, except in those with predominant activation of the fibrinolytic system with severe acute bleeding.
•Severe renal insufficiency (risk of accumulation).
•History of seizures.
•Analytical data and data obtained in the physical examination.
•Hypersensitivity to any component of the study drug formulation.
•Any other clinical condition or previous therapy that, in the opinion of the investigator, would make the patient ineligible to participate in the study or unable to comply with the dosing requirements.
•Prisoners or persons who are compulsorily detained (involuntary confinement) for the treatment of a psychiatric or physical illness (e.g., an infectious disease) are not eligible to participate in this study.

发起方

Coral Sánchez Pérez