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

Last updated: October 27, 2024
Sponsor: King Chulalongkorn Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Topical tranexamic acid administration

Clinical Study ID

NCT06289478
0151/67
  • Ages > 60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: Topical tranexamic acid administration
Phase:
Study Start date:
July 03, 2024
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Faculty of Medicine

    Bangkok, 10330
    Thailand

    Site Not Available

  • Faculty of Medicine, King Chulalongkorn Memorial Hospital

    Bangkok, 10330
    Thailand

    Active - Recruiting

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