Topical Tranexamic Acid (TXA) in Joint Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Topical Application of Tranexamic Acid in Joint Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937559
• Other study ID #: Pro00021253
• Status: Completed
• Phase: Phase 4
• Start date: April 2013
• Est. completion date: November 2018

Study information

• Verified date: April 2020
• Source: The Hawkins Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: November 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases
• Osteoarthritis
• Shoulder Arthropathy

Intervention

Biological:
• Tranexamic acid (TXA)
1.5g of TXA in 100ml normal saline solution

Drug:
• Normal saline

Locations

Country	Name	City	State
United States	Steadman Hawkins Clinic of the Carolinas - Greenville Health System	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
The Hawkins Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Perioperative Blood Transfusions		Duration of hospital stay, up to 4 days
Secondary	Number of Blood Units Transfused		Duration of hospital stay, up to 4 days
Secondary	Rate of Surgical Infections		Duration of hospital stay, up to 4 days
Secondary	Length of Hospital Stay		Duration of hospital stay
Secondary	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
Secondary	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