Phase 4
N=188
Topical Tranexamic Acid (TXA) in Joint Arthroplasty
Osteoarthritis · Hip Arthropathy · Shoulder Arthropathy
Bottom Line
View on ClinicalTrials.gov: NCT01937559 ↗Enrolled (actual)
188
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Post-operative Blood Loss — 1,062.88; 1,204.60; 933.92 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic acid (TXA) (Biological); Normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Hawkins Foundation
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Blood Loss |
1,062.88; 1,204.60; 933.92 | — |
| SECONDARY Number of Participants With Perioperative Blood Transfusions |
0; 0; 0 | — |
| SECONDARY Number of Blood Units Transfused |
0; 0; 0 | — |
| SECONDARY Rate of Surgical Infections |
0; 0; 0 | — |
| SECONDARY Length of Hospital Stay |
1.52; 1.64; 1.39 | — |
| SECONDARY Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE). |
84.87; 80.15; 6.24; 5.54; 89.06; 81.08 | — |
| SECONDARY Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
85.03; 79.95; 14.64; 13.46 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT01937559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.