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

King Chulalongkorn Memorial Hospital

Status: Enrolling

Conditions: Femoral Neck Fracture

Treatments: Drug: Topical tranexamic acid administration

Study type: Interventional

Funder types: Other

Identifiers

NCT06289478

0151/67

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

Retrograde Intraarticular Injection via Drain Tube

Experimental group

Description:

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

Treatment:

Drug: Topical tranexamic acid administration

Topical Soaking of Tranexamic Acid

Experimental group

Description:

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

Treatment:

Drug: Topical tranexamic acid administration

Standard procedure (placebo)

Placebo Comparator group

Description:

Standard wound irrigation

Treatment:

Drug: Topical tranexamic acid administration