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

NCT06289478 | Recruiting DMC

• 1 other identifier: 0151/67
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Femoral Neck Fracture

Keywords

tranexamic acid; femoral neck fracture; bipolar hemiarthroplasty; topical; blood transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Volume of blood transfusion

  2 years, or until complete enrollment

• Calculated blood loss

  2 years, or until complete enrollment

• Any adverse events

  2 years, or until complete enrollment

• In-hospital mortality

  During admission period

Study Arms (3)

Retrograde Intraarticular Injection via Drain Tube

EXPERIMENTAL

Tranexamic acid will be injected retrograde to the joint via drain tube after surgical wound closure

Drug: Topical tranexamic acid administration

Topical Soaking of Tranexamic Acid

EXPERIMENTAL

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

Standard procedure (placebo)

PLACEBO COMPARATOR

Standard wound irrigation

Drug: Topical tranexamic acid administration

Interventions

Topical tranexamic acid administration DRUG

Tranexamic acid will be topically administered in intervention groups

Retrograde Intraarticular Injection via Drain Tube; Standard procedure (placebo); Topical Soaking of Tranexamic Acid

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (2)

Faculty of Medicine, King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

RECRUITING

Faculty of Medicine

Bangkok, 10330, Thailand

NOT YET RECRUITING

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

Kanyakorn Riewruja, Medical degree

CONTACT

+66958644447; kanyakorn.riew@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 4, 2024
• Study Start: July 3, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

TH (2)