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

Study Overview
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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.

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

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

Conditions
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Hip Fractures

Intervention / Treatment
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* Drug: Tranexamic acid
* Other: Physiologic saline


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Extracapsular fracture with intravenous contraindication (control).<br>Physiological saline | Other: Physiologic saline<br>* Placebo<br>|
| Experimental: Extracapsular fracture with intravenous contraindication (experimental).<br>Amchafibrin | Drug: Tranexamic acid<br>* Intravenous or topical administration<br>|
| Placebo Comparator: Extracapsular fracture without intravenous contraindication (control).<br>Physiological saline | Other: Physiologic saline<br>* Placebo<br>|
| Experimental: Extracapsular fracture without intravenous contraindication (experimental).<br>Amchafibrin | Drug: Tranexamic acid<br>* Intravenous or topical administration<br>|
| Placebo Comparator: Intracapsular fracture with intravenous contraindication (control).<br>Physiological saline | Other: Physiologic saline<br>* Placebo<br>|
| Experimental: Intracapsular fracture with intravenous contraindication (experimental).<br>Amchafibrin | Drug: Tranexamic acid<br>* Intravenous or topical administration<br>|
| Active Comparator: Intracapsular fracture without intravenous contraindication (control).<br>Physiological saline | Other: Physiologic saline<br>* Placebo<br>|
| Experimental: Intracapsular fracture without intravenous contraindication (experimental).<br>Amchafibrin | Drug: Tranexamic acid<br>* Intravenous or topical administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood loss |  | From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation. | 
| Adverse events |  | 3,6,9 and 12 months | 
| Days at hospital |  | From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Fracture, Blood loss, tranexamic acid