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

B

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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