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Combined Tranexamic Acid Use in Total Hip Replacement Surgery

NCT07610863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-05-28

No results posted yet for this study

Summary

This prospective study evaluates whether combined intravenous and topical administration of tranexamic acid (TXA) can safely reduce blood loss in patients undergoing primary total hip replacement surgery. Tranexamic acid is commonly used during orthopedic surgery to decrease bleeding and reduce the need for blood transfusions.

Participants undergoing elective primary total hip arthroplasty are assigned to receive either intravenous TXA alone or a combination of intravenous and topical TXA applied directly around the hip joint during surgery. The study compares postoperative blood loss, changes in hemoglobin levels, transfusion requirements, length of hospital stay, and postoperative complications between the treatment groups.

The study also uses rotational thromboelastometry (ROTEM), a specialized blood coagulation monitoring method, to evaluate whether combined TXA administration affects blood clotting or increases the risk of thromboembolic complications such as deep vein thrombosis or pulmonary embolism.

Conditions

  • Total Hip Arthroplasty
  • Tranexamic Acid Administration
  • Perioperative Blood Loss
  • Coagulation Monitoring Using ROTEM

Interventions

DRUG

Intravenous Tranexamic Acid

Participants receive a single 1 g intravenous dose of tranexamic acid administered before surgical incision during primary total hip arthroplasty without additional topical application.

DRUG

Combined Intravenous and Intraarticular Tranexamic Acid

Participants receive tranexamic acid administered through two routes during primary total hip arthroplasty. A 1 g intravenous dose is administered before surgical incision, followed by an additional 2 g topical dose applied locally around the hip prosthesis during wound closure after implantation of the components and achievement of hemostasis.

Sponsors & Collaborators

  • St. Anne's University Hospital Brno, Czech Republic

    lead OTHER

Principal Investigators

  • Pavel Brančík · First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07610863 on ClinicalTrials.gov