NCT05489185

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

"Randomized, Double-blind Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Patients With Hip Fracture"

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 644 (estimated)
• Sponsor: Biogipuzkoa Health Research Institute · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hip Fractures

Interventions

Type	Name	Description
DRUG	Tranexamic acid	Intravenous or topical administration
OTHER	Physiologic saline	Placebo

Timeline

• Start date: 2023-05-30
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2022-08-05
• Last updated: 2023-05-17

Locations

1 site across 1 country: Spain