Efficacy and Safety of Retrograde Intraarticular Injection, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Femoral Neck Fractured Patients Undergoing Cementless Bipolar Hemiarthroplasty

Not Applicable

Recruiting

• Conditions: Femoral Neck Fracture
• Interventions: Drug: Topical tranexamic acid administration

• Registration Number: NCT06289478
• Lead Sponsor: King Chulalongkorn Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-02-25
• Study First Posted: 2024-03-04
• Study Start: 2024-07-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-27
• Last Update Posted: 2024-10-30
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard procedure (placebo)	Topical tranexamic acid administration	Standard wound irrigation
Topical Soaking of Tranexamic Acid	Topical tranexamic acid administration	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
Retrograde Intraarticular Injection via Drain Tube	Topical tranexamic acid administration	Tranexamic acid will be injected retrograde to the joint via drain tube after surgical wound closure

Primary Outcome Measures

Name	Time	Method
Rate of blood transfusion	2 years, or until complete enrollment	Proportion of patients received blood transfusion divided by total number of patient in a group

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Faculty of Medicine, King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Faculty of Medicine; 🇹🇭 Bangkok, Thailand