Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion

Evaluating the Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion in Hip Fracture Patients

Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. Limited research is available on its use in hip fracture patients. We hypothesize that the use of TXA preoperatively, perioperatively, and postoperatively will decrease blood loss and need for blood transfusion postoperatively.

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Drug: Saline solution; Drug: Tranexamic Acid (TXA)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sara Seegert, MSN, RN; Phone Number: 419-291-3441; Email: sara.seegert@promedica.org
• Study Contact Backup: Name: Michelle Barhite, RPh; Phone Number: 419-291-7709; Email: michelle.barhite@promedica.org

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Recruiting
      • ProMedica Toledo Hospital
      • Contact: Gregory Georgiadis, MD; Phone Number: 419-291-3858; Email: gregory.georgiadisMD@promedica.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over the age of 60 years
• Hip fracture requiring surgical intervention
• Signs consent and agrees to participate

Exclusion Criteria:

• Under the age of 60
• Does not sign consent or refuses participation
• Known hypersensitivity to tranexamic acid
• Multiple acute fractures
• Creatinine clearance <30
• History of seizures
• Active hormone therapy
• History of coagulation abnormality
• History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year or history or recurrent DVT/PE
• Myocardial infarction (MI) and/or stents within the past year
• History of intracranial hemorrhage
• Acquired defective color vision
• Patients admitted directly to nursing units or surgery without stay in the Emergency Center
• Patients who sustain fracture while hospitalized at ProMedica Toledo Hospital

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control Arm; Will receive intravenous Saline solution placebo bolus dose in the Emergency Center over 10 minutes. The subject will also receive intravenous Saline solution over 8 hours prior to surgery. Another dose will be administered at the time of incision and the final dose three hours later.	Drug: Saline solution; Saline solution is used as the placebo comparator; Other Names: normal saline
EXPERIMENTAL: Experimental Arm; Will receive intravenous Tranexamic Acid (TXA) 15mg/kg (maximum 1 gram) bolus dose over 10 minutes in the Emergency Center. The subject will also receive an intravenous dose of Tranexamic Acid (TXA) 15mg/kg over 8 hours prior to surgery. Another 15mg/kg dose of Tranexamic Acid (TXA) will be administered over 10 minutes at the time of incision and the final dose (15mg/kg) of Tranexamic Acid (TXA) intravenously over 10 minutes three hours later.	Drug: Tranexamic Acid (TXA); Tranexamic acid is an antifibrinolytic used to control bleeding; Other Names: Cyklokapron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of patients requiring packed Red Blood Cell transfusion	units, perioperative	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative blood loss	mL	24 hours
postoperative anemia	Hgb <7g/dL	72 hours

Collaborators and Investigators

• Sponsor: Gregory M Georgiadis MD
• Investigators: Principal Investigator: Gregory M Georgiadis, MD, ProMedica Toledo Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2017
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (ACTUAL): February 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: GG082015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes