Efficacy and Safety of Retrograde Intraarticular Injection Via Drain Tube, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Elderly Patients With Femoral Neck Fractures Undergoing Cementless Bipolar Hemiarthroplasty - a Randomized Controlled Trial (TXA)

Efficacy and Safety of Retrograde Intraarticular Injection Via Drain Tube, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Elderly Patients With Femoral Neck Fractures Undergoing Bipolar Hemiarthroplasty - a Randomized Controlled Trial

The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are:

• The efficacy in reducing blood transfusion for topical tranexamic acid administration
• The safety of tranexemic acid, topically used

As having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration.

Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion.

Study Overview

• Status: Not yet recruiting
• Conditions: Femoral Neck Fracture; Bipolar Hemiarthroplasty
• Intervention / Treatment: Drug: Topical tranexamic acid administration

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kanyakorn Riewruja, Medical degree; Phone Number: +66958644447; Email: kanyakorn.riew@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Faculty of Medicine
    • Contact: Kanyakorn Riewruja; Phone Number: +66-95-864-4447; Email: kanyakorn.riew@gmail.com
    • Principal Investigator: Kanyakorn Riewruja, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Elderly patients (age > 60 years)
• Femoral neck fractures from low energy mechanism
• Household ambulator
• Undergoing cementless bipolar hemiarthroplasty at KCMH
• Informed consent

Exclusion Criteria:

• Allergy to TXA
• History of VTE
• History of hip surgery, pathological fracture, hip infection
• Congenital or acquired coagulopathy
• Hb < 10 g/dL or Platelet < 140,000

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Retrograde Intraarticular Injection via Drain Tube; Tranexamic acid will be injected retrograde to the joint via drain tube after surgical wound closure	Drug: Topical tranexamic acid administration; Tranexamic acid will be topically administered in intervention groups
Experimental: Topical Soaking of Tranexamic Acid; Tranexamic acid will be placed to soak the intramedullary canal of the femur and surgical area after sheath closure for 5 minutes and completely remove by sunction	Drug: Topical tranexamic acid administration; Tranexamic acid will be topically administered in intervention groups
Placebo Comparator: Standard procedure (placebo); Standard wound irrigation	Drug: Topical tranexamic acid administration; Tranexamic acid will be topically administered in intervention groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of blood transfusion	Proportion of patients received blood transfusion divided by total number of patient in a group	2 years, or until complete enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of blood transfusion	total volume of blood transfusion per each patient	2 years, or until complete enrollment
Calculated blood loss	Calculating using Nadler and Goss formula	2 years, or until complete enrollment
Any adverse events	Adverse events include wound complication, deep vein thrombosis, pulmonary embolism, and other complication	2 years, or until complete enrollment
In-hospital mortality	In-hospital mortality	During admission period

Collaborators and Investigators

• Sponsor: King Chulalongkorn Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: blood transfusion; tranexamic acid; topical; femoral neck fracture; bipolar hemiarthroplasty
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 0151/67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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