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

Femoral Neck Fracture Clinical Trial

— TXA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06289478
• Other study ID #: 0151/67
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2026

Study information

• Verified date: February 2024
• Source: King Chulalongkorn Memorial Hospital
• Contact: Kanyakorn Riewruja, Medical degree
• Phone: +66958644447
• Email: kanyakorn.riew[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone

Intervention

Drug:
• Topical tranexamic acid administration
Tranexamic acid will be topically administered in intervention groups

Locations

Country	Name	City	State
Thailand	Faculty of Medicine	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

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