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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05489185
• Other study ID #: 2020_TRANEXAMICO
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 30, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: August 2022
• Source: Asociacion Instituto Biodonostia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Prevention and treatment of bleeding due to general or local fibrinolysis

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 644
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Hemorrhage
• Hip Fractures

Intervention

Drug:
• Tranexamic acid
Intravenous or topical administration

Other:
• Physiologic saline
Placebo

Locations

Country	Name	City	State
Spain	Asociación Instituto Biodonostia	San Sebastián	Guipuzcoa

Sponsors (1)

Lead Sponsor	Collaborator
Asociacion Instituto Biodonostia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood transfusion	Transfusion rate from patient admission to hospital discharge.	From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Secondary	Total blood loss		From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Secondary	Adverse events		3,6,9 and 12 months
Secondary	Days at hospital		From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.