Topical Tranexamic Acid (TXA) in Joint Arthroplasty

Phase 4

Completed

• Conditions: Osteoarthritis; Hip Arthropathy; Shoulder Arthropathy
• Interventions: Drug: Normal saline; Biological: Tranexamic acid (TXA)

• Registration Number: NCT01937559
• Lead Sponsor: The Hawkins Foundation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-08-30
• Study First Submitted QC: 2013-09-07
• Study First Posted: 2013-09-09
• Primary Completion: 2018-06
• Study Completion: 2018-11
• Status Verified: 2020-04
• Results First Submitted: 2020-04-10
• Results First Submitted QC: 2020-04-24
• Last Update Submitted: 2020-04-24
• Results First Posted: 2020-05-05
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Normal saline	Normal saline
Tranexamic acid (TXA)	Tranexamic acid (TXA)	Tranexamic acid (TXA) administered intravenously
Topical Tranexamic acid (TXA)	Tranexamic acid (TXA)	Tranexamic acid (TXA) applied topically

Primary Outcome Measures

Name	Time	Method
Post-operative Blood Loss	Duration of hospital stay, up to 4 days	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.

Secondary Outcome Measures

Name	Time	Method
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
Number of Participants With Perioperative Blood Transfusions	Duration of hospital stay, up to 4 days
Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE).	6 months post-surgery	* 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."
Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC)	6 months after surgery	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.

Trial Locations

Locations (1)

Steadman Hawkins Clinic of the Carolinas - Greenville Health System; 🇺🇸 Greenville, South Carolina, United States