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NCT Number: NCT06289478

Efficacy and Safety of Topical Tranexamic Acid (TXA) Administration Cementless Bipolar Hemiarthroplasty for Femoral Neck Fracture - 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.

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Key information

Conditions

Femoral Neck Fracture Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Bangkok, Thailand

Loading trial locations.

About this study

Perioperative blood loss and transfusion are common in elderly patients undergoing bipolar hemiarthroplasty for femoral neck fractures, and are associated with anemia-related morbidity and transfusion-related risk. Although tranexamic acid (TXA) reduces blood loss and transfusion in elective arthroplasty, topical administration has been proposed to preserve local hemostatic efficacy while limiting systemic exposure in this comorbid population, but the optimal topical route in hip fracture surgery remains uncertain.

This study compared the efficacy and safety of topical soaking (TS) and intra-articular (IA) TXA with placebo in patients undergoing bipolar hemiarthroplasty.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrograde Intraarticular Injection via Drain Tube

Drug

Tranexamic acid will be injected via drain tube after wound closure

Topical Soaking of Tranexamic Acid

Drug

Tranexamic acid will be topically administered by soaking method

Placebo Comparator: Standard procedure (placebo)

Drug

Standard wound management

Primary outcomes

  1. Rate of blood transfusion

    Time frame: 2 years, or until complete enrollment

    Proportion of patients received blood transfusion divided by total number of patient in a group

Secondary outcomes

  1. Volume of blood transfusion

    Time frame: 2 years, or until complete enrollment

    total volume of blood transfusion per each patient

  2. Calculated blood loss

    Time frame: 2 years, or until complete enrollment

    Calculating using Nadler and Goss formula

  3. Any adverse events

    Time frame: 2 years, or until complete enrollment

    Adverse events include wound complication, deep vein thrombosis, pulmonary embolism, and other complication

  4. In-hospital mortality

    Time frame: During admission period

    In-hospital mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Riewruja, Medical degree

CONTACT

[email protected]

+66958644447

Tantavisut, MD., PhD.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

King Chulalongkorn Memorial Hospital

Other

Registry information

Official study 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

Acronym: TXA

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 4, 2024
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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