Clinical trial NCT05489185: Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Hip Fracture Patients.
Official title: "Randomized, Double-blind Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Patients With Hip Fracture"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hip Fractures
Keywords: Hip Fracture
Blood loss
tranexamic acid
Lead sponsor: Biogipuzkoa Health Research Institute
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 644
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Prevention and treatment of bleeding due to general or local fibrinolysis

Eligibility criteria: Inclusion Criteria:

* Patients over or equal to 65 years of age, of both sexes, who are going to be operated on for a hip fracture
* Accept participation in the study (informed consent that will be signed by the patient or family member/legal representative depending on the patient's degree of autonomy).

Exclusion Criteria:

* Under treatment with another experimental drug (who is not participating in another clinical trial with an experimental drug).
* The refusal of the patient or their relatives/legal representative to participate in the study.
* Known allergy to TXA ( Hipersensivity to TXA o to any of the excipients).
* Patients with a history of seizures.
* Patients with severe renal and hepatic insufficiency.
* Patients with venous thrombosis.
* Patients with active concomitant bleeding of renal origin.

Primary outcomes:
measure: Blood transfusion
timeFrame: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Secondary outcomes:
measure: Total blood loss
timeFrame: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
measure: Adverse events
timeFrame: 3,6,9 and 12 months
measure: Days at hospital
timeFrame: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Other outcomes:
Locations:
city: San Sebastián
country: Spain
facility: Asociación Instituto Biodonostia
state: Guipuzcoa
Study officials:
References: