Efficacy and Safety of Topical Tranexamic Acid (TXA) Administration Cementless Bipolar Hemiarthroplasty for Femoral Neck Fracture - a Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorKing Chulalongkorn Memorial Hospital

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Elderly patients (age > 60 years)

Femoral neck fractures from low energy mechanism

Household ambulator

Undergoing cementless bipolar hemiarthroplasty at KCMH

Disqualifiers

Allergy to TXA

History of VTE

History of hip surgery, pathological fracture, hip infection

Congenital or acquired coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Retrograde Intraarticular Injection via Drain TubeExperimental treatment 1 intervention
Group B: Topical Soaking of Tranexamic AcidExperimental treatment 1 intervention
Group C: Standard procedure (placebo)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of blood transfusion

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

Time frame
2 years, or until complete enrollment

Secondary outcomes

1

Volume of blood transfusion

total volume of blood transfusion per each patient

Time frame
2 years, or until complete enrollment
2

Calculated blood loss

Calculating using Nadler and Goss formula

Time frame
2 years, or until complete enrollment
3

Any adverse events

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

Time frame
2 years, or until complete enrollment
4

In-hospital mortality

In-hospital mortality

Time frame
During admission period

Other outcomes

Sponsors and contacts

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