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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

644 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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Prevention and treatment of bleeding due to general or local fibrinolysis

Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Amchafibrin

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

Intravenous or topical administration

Interventions

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Tranexamic acid

Intravenous or topical administration

Intervention Type DRUG

Physiologic saline

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No