Topical Tranexamic Acid (TXA) in Joint Arthroplasty

Topical Application of Tranexamic Acid in Joint Arthroplasty

The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Hip Arthropathy; Shoulder Arthropathy
• Intervention / Treatment: Drug: Normal saline; Biological: Tranexamic acid (TXA)

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Shoulders: All adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study.

Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study.

Exclusion Criteria:

• allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance <30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin <11g/dl in females and < 12g/dl in males).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline; Normal saline	Drug: Normal saline
Experimental: Topical Tranexamic acid (TXA); Tranexamic acid (TXA) applied topically	Biological: Tranexamic acid (TXA); 1.5g of TXA in 100ml normal saline solution; Other Names: Cyklokapron
Active Comparator: Tranexamic acid (TXA); Tranexamic acid (TXA) administered intravenously	Biological: Tranexamic acid (TXA); 1.5g of TXA in 100ml normal saline solution; Other Names: Cyklokapron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Blood Loss	Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion.	Duration of hospital stay, up to 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Perioperative Blood Transfusions		Duration of hospital stay, up to 4 days
Number of Blood Units Transfused		Duration of hospital stay, up to 4 days
Rate of Surgical Infections		Duration of hospital stay, up to 4 days
Length of Hospital Stay		Duration of hospital stay
Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE).	Single Assessment Numeric Evaluation (SANE): A single question that asks "How would you rate your hip today as a percentage of normal (0% to 100% scale with 100% being normal)?" 0 indicates an abnormal shoulder, whereas 100% indicates a perfectly normal shoulder.; Euroqol-5D (EQ-5D): The EQ-5D is a patient-reported overall health questionnaire, with 100 indicating "The best health you can imagine" and 0 indicating "The worst health you can imagine."; Global Rating of Change Scale (GRoC): Provide a means of measuring self-perceived change in health status. The main purpose is to quantify the extent to which a patient has improved or deteriorated over time. The outcome is measured on a scale of -7 to 7, with -7 being the hip is "a very great deal worse from before surgery" and 7 being the hip is "a very great deal better from before surgery."	6 months post-surgery
Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC)	Harris Hip Score: Consists of 10 question items evaluating pain, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing less dysfunction and better outcomes, whereas lower scores represent more dysfunction and worse outcomes. Western Ontario and McMaster Universities Arthritis Index (WOMAC): Consists of 24 questions evaluating hip pain, stiffness and function. The score is normalized to a 100 point scale, where 0 indicates a poor outcome and 100 indicates the best outcome.	6 months after surgery

Collaborators and Investigators

• Sponsor: The Hawkins Foundation
• Investigators: Principal Investigator: Brian Burnikel, MD, Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: August 30, 2013
• First Submitted That Met QC Criteria: September 7, 2013
• First Posted (Estimate): September 9, 2013

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: tranexamic acid (TXA)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: Pro00021253