Tranexamic Acid Use in Acute Hip Fractures

The Use of Tranexamic Acid to Reduce the Need for Transfusion 1 Week Post-operatively for Hemiarthroplasty or Intramedullary Nailing Needed to Correct Acute Hip Fractures

BACKGROUND: Tranexamic acid (TXA) has been used widely for the reduction of post operative blood loss for various orthopaedic procedures including but not limited to total hip arthroplasty and total knee arthroplasty. A recent multihospital meta-analysis conducted in 2013 showed that patients who received TXA showed a significant reduction in post-operative transfusion (20.1% to 7.7%). The procedures the investigators will be evaluating are the intramedullary nail for intertrochanteric fracture and hip hemiarthroplasty. These procedures are similar to the total hip or knee replacement in that they can result in significant blood loss that requires a post operative transfusion.

STUDY PURPOSE: To determine the efficacy of TXA to decrease the rate of post-operative transfusion for acute hip fractures repaired with the following two methods, intramedullary nailing for intertrochanteric fracture and hemiarthroplasty.

METHODS: The model for the study is a prospective randomized control trial. Patients will be placed in one of two arms of the study after passing our inclusion criteria. The arms will be for either the intramedullary nailing for intertrochanteric fracture or for hemiarthroplasty. These two categories will be subdivided into those receiving TXA and those not receiving TXA. The patients in each category will have standard post-operative care and laboratory testing. The investigators will record the patients in either arm of the study, whether it be no TXA or TXA, who require post-operative transfusion within 1 week of the operation.

Study Overview

• Status: Completed
• Conditions: Acute Hip Fractures
• Intervention / Treatment: Other: Placebo; Drug: Tranexamic Acid

Detailed Description

This is a prospective randomized control trial. Patients scheduled for either intramedullary nailing for intertrochanteric fractures or for hemiarthroplasty will be selected for the study population.

The proposed research is needed to bridge the gap between the efficacy of TXA in elective, non-emergency procedures (such as total knee arthoplasty and total hip arthroplasty) and its efficacy in emergent acute hip fracture interventions. This study will use intravenous TXA (1g pre-op and 1g post-op) to study its effect on both the reduction of blood loss during intramedullary nail for intertrochanteric fractures and hemiarthroplasty procedures, and the subsequent reduction in the rate of blood transfusion in this patient population.

Both study and control groups will have standard post-operative care and laboratory testing and will be followed for one year post-operatively to record adverse events.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Roanoke Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Geriatric patients age 65 or older who require surgery for a low energy trauma hip fracture

Exclusion Criteria:

• Prothrombotic state
• Cardiac stent within the past year with corresponding antiplatelet therapy
• Mechanical heart valves
• Deep vein thrombosis history
• Aortic stenosis
• Currently on Coumadin
• Malignancy
• Kidney dialysis
• Non-English speaking patients
• Medications contraindicated with tranexamic acid.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Hemiarthroplasty - Placebo; Patients are placed into this arm based on the type of surgery performed and are randomized to receive placebo	Other: Placebo; intravenous dose; Other Names: Saline
Experimental: Intramedullary nail - Tranexamic Acid; Patients are placed into this arm based on the type of surgery performed and are randomized to receive tranexamic acid	Drug: Tranexamic Acid; intravenous dose; Other Names: TXA
Experimental: Hemiarthroplasty - Tranexamic Acid; Patients are placed into this arm based on the type of surgery performed and are randomized to receive tranexamic acid	Drug: Tranexamic Acid; intravenous dose; Other Names: TXA
Placebo Comparator: Intramedullary nail - Placebo; Patients are placed into this arm based on the type of surgery performed and are randomized to receive placebo	Other: Placebo; intravenous dose; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion reduction rate	Determine the efficacy of Tranexamic Acid (TXA) in the reduction of allogenic blood transfusion within 1 week following either hemiarthroplasty or intramedullary nailing for intertrochanteric fracture.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tranexamic acid post operative complications	Determine what effect TXA has on post-operative complications within 1 year following surgery for either hemiarthroplasty or intramedullary nailing for intertrochanteric fracture.	1 year

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Investigators: Principal Investigator: Trevor Owen, MD, Carilion Clinic

Publications and helpful links

General Publications

• Poeran J, Rasul R, Suzuki S, Danninger T, Mazumdar M, Opperer M, Boettner F, Memtsoudis SG. Tranexamic acid use and postoperative outcomes in patients undergoing total hip or knee arthroplasty in the United States: retrospective analysis of effectiveness and safety. BMJ. 2014 Aug 12;349:g4829. doi: 10.1136/bmj.g4829.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): February 4, 2022
• Study Completion (Actual): May 22, 2022

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimate): October 28, 2016

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Hemiarthroplasty; Transfusion; Tranexamic acid; Intramedullary nail
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: MD2016

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