Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Hip Fracture Patients.

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asociacion Instituto Biodonostia
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Patients over 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.

• Patients with a history of seizures.

• Patients with severe renal and hepatic insufficiency.

• Patients with hypersensitivity to any of the excipients indicated in the tranexamic acid data sheet, acute arterial or venous thrombosis.

• Patients with active concomitant bleeding of renal origin.