Single Dose of Tranexamic Acid and Blood Loss, in Elderly Patients With Hip Fracture

August 15, 2017 updated by: Vasileios S. Nikolaou, National and Kapodistrian University of Athens

Single Dose of Tranexamic Acid at the Time of Surgery and Blood Loss, in Elderly Patients Undergoing Hip Fracture Surgery

The aim of this study is to investigate the hypothesis that single dose of tranexamic acid (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing and cemented hemiarthroplasty respectively. After application of inclusion and exclusion criteria, patients will be randomized in two groups. Group 1 will include patients that receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that receive normal saline (control group).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

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

  • Greece
    • Attika
      • Athens, Attika, Greece, 14233

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

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive elderly patients (age >75 yo) undergoing hip fracture surgery for a stable or unstable intertrochanteric hip fracture with the insertion of a short intramedullary nail (IMN) as well as patients treated surgically with cemented hemiarthroplasty for acute femoral neck (subcapital) hip fracture.

Exclusion Criteria:

  • Any contraindication for tranexamic acid
  • Multiple fractures
  • Requirement for anticoagulant therapy that could not be stopped.
  • Ongoing thromboembolic event
  • reduced kidney function
  • malignancy,
  • pathological fracture
  • previous operation on the affected hip
  • Active coronary artery disease (event in the past 12 months).

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
intravenous tranexamic acid, 15mg/kg, preoperatively, single dose
Drug: Tranexamic Acid 15mg/kg , iv, Single Dose
Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose
Placebo Comparator: Group 2
Intravenous normal saline, 100mg, preoperatively, single dose
Drug: Normal Saline, 100mg, iv, Singe dose
Normal Saline, 100mg, administered intravenously, preoperatively in single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of transfusions of allogeneic RBC from surgery up to day 4
Time Frame: 5 days
5 days
total blood loss from surgery to day
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of vascular events
Time Frame: 3 months
3 months
Incidence of deaths
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

National and Kapodistrian University of Athens

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

January 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

August 15, 2017

First Posted (Actual)

August 16, 2017

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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