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

May 16, 2023 updated by: Asociacion Instituto Biodonostia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Prevention and treatment of bleeding due to general or local fibrinolysis

Study Type

Interventional

Enrollment (Anticipated)

644

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Guipuzcoa
      • San Sebastián, Guipuzcoa, Spain, 20014
        • Asociación Instituto Biodonostia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood transfusion
Time Frame: 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.
From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociacion Instituto Biodonostia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 30, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_TRANEXAMICO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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