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

NCT05489185 | Unknown Phase 4

• 1 other identifier: 2020_TRANEXAMICO
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Keywords

Hip Fracture; Blood loss; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (8)

Extracapsular fracture with intravenous contraindication (control).

PLACEBO COMPARATOR

Physiological saline

Other: Physiologic saline

Extracapsular fracture with intravenous contraindication (experimental).

EXPERIMENTAL

Amchafibrin

Drug: Tranexamic acid

Extracapsular fracture without intravenous contraindication (control).

PLACEBO COMPARATOR

Physiological saline

Other: Physiologic saline

Extracapsular fracture without intravenous contraindication (experimental).

EXPERIMENTAL

Amchafibrin

Drug: Tranexamic acid

Intracapsular fracture with intravenous contraindication (control).

PLACEBO COMPARATOR

Physiological saline

Other: Physiologic saline

Intracapsular fracture with intravenous contraindication (experimental).

EXPERIMENTAL

Amchafibrin

Drug: Tranexamic acid

Intracapsular fracture without intravenous contraindication (control).

ACTIVE COMPARATOR

Physiological saline

Other: Physiologic saline

Intracapsular fracture without intravenous contraindication (experimental).

EXPERIMENTAL

Amchafibrin

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

Intravenous or topical administration

Extracapsular fracture with intravenous contraindication (experimental).; Extracapsular fracture without intravenous contraindication (experimental).; Intracapsular fracture with intravenous contraindication (experimental).; Intracapsular fracture without intravenous contraindication (experimental).

Physiologic saline OTHER

Placebo

Extracapsular fracture with intravenous contraindication (control).; Extracapsular fracture without intravenous contraindication (control).; Intracapsular fracture with intravenous contraindication (control).; Intracapsular fracture without intravenous contraindication (control).

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogipuzkoa Health Research Institute: lead

Study Sites (1)

Asociación Instituto Biodonostia

San Sebastián, Guipuzcoa, 20014, Spain

Location

MeSH Terms

Conditions

Hip Fractures; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 5, 2022
• Study Start: May 30, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: May 17, 2023

Record last verified: 2022-08

Locations

ES (1)