Hip fracture in elderly patients is a pathology with a high economic and health impact on the patient himself and on the National Health System, especially considering the significant aging of the population of the Basque Country. Despite advances, hip fracture remains in the clinical groups with the highest in-hospital mortality. Hip fracture is associated with numerous adverse events and high mortality. Numerous antifibrinolytics, such as tranexamic acid (TXA), have been used to limit bleeding in orthopedic surgery and thus prevent the need for blood transfusion. Numerous studies have shown that the use of tranexamic acid does not increase the risk of thrombosis. It is proposed to carry out clinical research with drugs without commercial interest. A randomized, double-blind clinical trial to assess the efficacy of tranexamic acid in reducing blood loss in elderly patients with hip fracture.
Prevention and treatment of bleeding due to general or local fibrinolysis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
644
Intravenous or topical administration
Placebo
Asociación Instituto Biodonostia
San Sebastián, Guipuzcoa, Spain
Blood transfusion
Transfusion rate from patient admission to hospital discharge.
Time frame: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Total blood loss
Time frame: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Adverse events
Time frame: 3,6,9 and 12 months
Days at hospital
Time frame: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
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