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

Sponsor

Asociacion Instituto Biodonostia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05489185

Collaborator

(none)

644

Enrollment

Location

Arms

Anticipated Duration (Months)

19.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures	Drug: Tranexamic acid Other: Physiologic saline	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

644 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Blood transfusion [From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.]
Transfusion rate from patient admission to hospital discharge.

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.