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

Biogipuzkoa Health Research Institute

Status and phase: Not yet enrolling; Phase 4

Conditions: Hip Fractures

Treatments: Drug: Tranexamic acid; Other: Physiologic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05489185

2020_TRANEXAMICO

Details and patient eligibility

About

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.

Full description

Prevention and treatment of bleeding due to general or local fibrinolysis

Enrollment: 644 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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644 participants in 8 patient groups, including a placebo group

Extracapsular fracture with intravenous contraindication (control).

Placebo Comparator group

Description:

Physiological saline

Treatment:

Other: Physiologic saline

Extracapsular fracture with intravenous contraindication (experimental).

Experimental group

Description:

Amchafibrin

Treatment:

Drug: Tranexamic acid

Extracapsular fracture without intravenous contraindication (control).

Placebo Comparator group

Description:

Physiological saline

Treatment:

Other: Physiologic saline

Extracapsular fracture without intravenous contraindication (experimental).

Experimental group

Description:

Amchafibrin

Treatment:

Drug: Tranexamic acid

Intracapsular fracture with intravenous contraindication (control).

Placebo Comparator group

Description:

Physiological saline

Treatment:

Other: Physiologic saline

Intracapsular fracture with intravenous contraindication (experimental).

Experimental group

Description:

Amchafibrin

Treatment:

Drug: Tranexamic acid

Intracapsular fracture without intravenous contraindication (control).

Active Comparator group

Description:

Physiological saline

Treatment:

Other: Physiologic saline

Intracapsular fracture without intravenous contraindication (experimental).

Experimental group

Description:

Amchafibrin

Treatment:

Drug: Tranexamic acid