Back to resultsTopical Tranexamic Acid (TXA) in Joint Arthroplasty
Primary Purpose
Osteoarthritis, Hip Arthropathy, Shoulder Arthropathy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid (TXA)
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring tranexamic acid (TXA)
Eligibility Criteria
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).
Sites / Locations
- Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Topical Tranexamic acid (TXA)
Saline
Tranexamic acid (TXA)
Arm Description
Tranexamic acid (TXA) applied topically
Normal saline
Tranexamic acid (TXA) administered intravenously
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With Perioperative Blood Transfusions
Number of Blood Units Transfused
Rate of Surgical Infections
Length 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."
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01937559
Brief Title
Topical Tranexamic Acid (TXA) in Joint Arthroplasty
Official Title
Topical Application of Tranexamic Acid in Joint Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hawkins Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip Arthropathy, Shoulder Arthropathy
Keywords
tranexamic acid (TXA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical Tranexamic acid (TXA)
Arm Type
Experimental
Arm Description
Tranexamic acid (TXA) applied topically
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Normal saline
Arm Title
Tranexamic acid (TXA)
Arm Type
Active Comparator
Arm Description
Tranexamic acid (TXA) administered intravenously
Intervention Type
Biological
Intervention Name(s)
Tranexamic acid (TXA)
Other Intervention Name(s)
Cyklokapron
Intervention Description
1.5g of TXA in 100ml normal saline solution
Intervention Type
Drug
Intervention Name(s)
Normal saline
Primary Outcome Measure Information:
Title
Post-operative Blood Loss
Description
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.
Time Frame
Duration of hospital stay, up to 4 days
Secondary Outcome Measure Information:
Title
Number of Participants With Perioperative Blood Transfusions
Time Frame
Duration of hospital stay, up to 4 days
Title
Number of Blood Units Transfused
Time Frame
Duration of hospital stay, up to 4 days
Title
Rate of Surgical Infections
Time Frame
Duration of hospital stay, up to 4 days
Title
Length of Hospital Stay
Time Frame
Duration of hospital stay
Title
Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE).
Description
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."
Time Frame
6 months post-surgery
Title
Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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.
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Burnikel, MD
Organizational Affiliation
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topical Tranexamic Acid (TXA) in Joint Arthroplasty
We'll reach out to this number within 24 hrs