Combined Tranexamic Acid Use in Total Hip Replacement Surgery

NCT07610863 | Completed

• 2 other identifiers: IIT/2022/BRIdentification Number: 2212020
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hip arthroplasty; rotational thromboelastometry; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Total Postoperative Blood Loss Measured by Surgical Drain Output and Hemoglobin Change

  Total postoperative blood loss measured in milliliters during the first 48 hours after primary total hip arthroplasty, calculated using surgical drain output and perioperative hemoglobin level changes.

  Up to 48 hours after surgery

Secondary Outcomes (3)

• Clotting Time (CT) Measured by ROTEM EXTEM Assay

  Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery

• Maximum Clot Firmness (MCF) Measured by ROTEM EXTEM Assay

  Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery

• Maximum Lysis (ML) Measured by ROTEM EXTEM Assay

  Baseline (15-20 minutes before intravenous TXA administration), 30 minutes after intravenous TXA administration, and 1 hour after surgery

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants receive 1 g intravenous tranexamic acid before surgical incision and an additional 2 g topical tranexamic acid applied locally around the prosthesis during wound closure in primary total hip arthroplasty.

Drug: Combined Intravenous and Intraarticular Tranexamic Acid

Intravenous TXA Only

ACTIVE COMPARATOR

Participants receive 1 g intravenous tranexamic acid before surgical incision during primary total hip arthroplasty without additional topical tranexamic acid administration.

Drug: Intravenous Tranexamic Acid

Interventions

Combined Intravenous and Intraarticular Tranexamic Acid DRUG

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.

Intervention Group

Intravenous Tranexamic Acid DRUG

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

Intravenous TXA Only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults undergoing elective primary cementless total hip arthroplasty for primary hip osteoarthritis
• Preoperative hemoglobin level ≥130 g/L
• Ability to provide written informed consent

You may not qualify if:

• Post-traumatic or secondary hip arthritis
• Known allergy or hypersensitivity to tranexamic acid
• History of deep vein thrombosis or pulmonary embolism
• Current anticoagulant therapy
• Known coagulation disorder
• Body mass index (BMI) \>40 kg/m²
• Significant hepatic or renal dysfunction
• Type 1 diabetes mellitus
• Significant cardiovascular disease
• Traumatic indication for total hip arthroplasty

Sponsors & Collaborators

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

Study Sites (1)

First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia

Brno, Czechia, 60200, Czechia

Location

Study Officials

• Pavel Brančík

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

CZ (1)