Extended Post-operative Oral TXA in Primary THA

Extended Post-operative Oral TXA vs.Standard Perioperative TXA in Primary TJA: A Randomized, Double-Blind, Placebo-Controlled Trial

The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis. The main question it aims to answer is: Does extended post-operative oral TXA improve functional outcomes at 6 weeks post-operatively compared to standard perioperative TXA alone? Researchers will compare patients receiving extended oral TXA to patients receiving matching placebo capsules on the same schedule to see if the extended TXA regimen reduces blood loss, improves early functional outcomes, and reduces pain without increasing complication rates. Participants will receive standard perioperative oral TXA (1.95 g) prior to surgical incision, along with standard VTE prophylaxis. They will be randomly assigned to receive either oral TXA or matching placebo capsules once daily on post-operative days 1, 2, and 3. Participants will attend follow-up visits at 2, 6, and 12 weeks post-operatively to complete functional outcome questionnaires, pain assessments, and - for knee replacement patients - range of motion measurements.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis (OA) of the Knee; Osteoarthritis (OA) of the Hip
• Intervention / Treatment: Drug: Extended oral tranexamic acid regimen; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ryland Kagan, MD; Phone Number: 503 494-6400; Email: kagan@ohsu.edu
• Study Contact Backup: Name: Madison Hayes-Lattin, MD; Phone Number: 503) 494-6400; Email: hayeslam@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years
• Undergoing primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis
• Ability to provide written informed consent
• Willingness to comply with study protocol

Exclusion Criteria:

• History of venous thromboembolism (DVT or PE)
• Active malignancy
• Allergy or contraindication to tranexamic acid (TXA)
• Post-operative anticoagulation therapy other than aspirin
• History of color blindness or retinal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extended Oral TXA; Participants will receive standard 1.95mg pre-operative oral TXA dose in addition to 1.95mg oral TXA on post-operative days 1, 2, and 3.	Drug: Extended oral tranexamic acid regimen; Participants in the intervention group will receive 1.95mg of oral tranexamic acid on post-operative day 1, 2, and 3.
Placebo Comparator: Placebo; Patients will receive standard pre-operative 1.95mg oral TXA, followed by a placebo pill on post-operative days 1, 2 and 3.	Drug: Placebo; Patients will receive an oral placebo medication on post-operative day 1, 2, and 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-week KOOS JR (TKA) or HOOS JR (THA) score	Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 6 weeks post-operatively.	At 6 weeks from timing of surgical intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-week KOOS JR (TKA) or HOOS JR (THA) score	Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 2 weeks post-operatively.	At 2 weeks from timing of surgical intervention
12-week KOOS JR (TKA) or HOOS JR (THA) score	Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 12 weeks post-operatively.	At 12 weeks from timing of surgical intervention
2-week VAS pain score	Visual analog scale (VAS) pain score at 2 weeks post-operatively	At 2 weeks from timing of surgical intervention
6-week VAS pain score	Visual analog scale (VAS) pain score at 6 weeks post-operatively	At 6 weeks from timing of surgical intervention
12-week VAS pain score	Visual analog scale (VAS) pain score at 12 weeks post-operatively	At 12 weeks from timing of surgical intervention
6-week absolute knee flexion	Degrees of knee flexion achieved at the 6 week post-operative mark for patients undergoing Total Knee Arthroplasty	At 6 weeks from timing of surgical intervention
Transfusion rate	Percentage of patients per arm requiring post-operative transfusion of blood products	From enrollment to end of treatment at 12 weeks from timing of surgical intervention
Blood product units transfused	For each arm, the average number of blood product units transfused per patient	From enrollment to end of treatment at 12 weeks from timing of surgical intervention
Incidence of Symptomatic DVT	The number of post-operative symptomatic deep vein thromboses identified in each arm	From enrollment to end of treatment at 90 days from timing of surgical intervention
Incidence of Symptomatic PE	The number of post-operative symptomatic pulmonary embolisms identified in each arm	From enrollment to end of treatment at 90 days from timing of surgical intervention
Incidence of Acute Coronary Sndrome	The number of cases of post-operative acute coronary syndrome, defined as an ST-elevation myocardial infarction (STEMI), a non-ST-elevation myocardial infarction (NSTEMI), or unstable angina.	From enrollment to end of treatment at 90 days from timing of surgical intervention
Incidence of Cerebrovascular Accident	The number of post-operative cerebrovascular accidents (CVAs), defined as ischemic or hemorrhagic stroke.	From enrollment to end of treatment at 90 days from timing of surgical intervention
Rate of Readmission	The number of patients per arm requiring readmission for any reason within 90 days of surgical intervention.	From enrollment to end of treatment at 12 weeks from timing of surgical intervention
Rate of Reoperation	The number of patients per arm requiring reoperation for any indication within 90 days of surgical intervention.	From enrollment to end of treatment at 90 days from timing of surgical intervention
All-cause Mortality Rate	The number of patients deceased of any cause within 90 days of surgical intervention.	From enrollment to end of treatment at 90 days from timing of surgical intervention

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Arthroplasty; Tranexamic acid; Patient Reported Outcomes
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 30119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No