Extended Post-operative Oral TXA in Primary THA

NCT07685743 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 30119
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis (OA) of the Knee; Osteoarthritis (OA) of the Hip

Keywords

Tranexamic acid; Patient Reported Outcomes; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 6-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) 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. Scale for booth outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.

  At 6 weeks from timing of surgical intervention

Secondary Outcomes (15)

• 2-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score

  At 2 weeks from timing of surgical intervention

• 12-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score

  At 12 weeks from timing of surgical intervention

• 2-week Visual Analog Scale (VAS) pain score

  At 2 weeks from timing of surgical intervention

• 6-week Visual Analog Scale (VAS) pain score

  At 6 weeks from timing of surgical intervention

• 12-week Visual Analog Scale (VAS) pain score

  At 12 weeks from timing of surgical intervention

Study Arms (2)

Extended Oral TXA

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Extended oral tranexamic acid regimen DRUG

Participants in the intervention group will receive 1.95mg of oral tranexamic acid on post-operative day 1, 2, and 3.

Extended Oral TXA

Placebo DRUG

Patients will receive an oral placebo medication on post-operative day 1, 2, and 3.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Ryland Kagan, MD

CONTACT

503 494-6400; kagan@ohsu.edu

Madison Hayes-Lattin, MD

CONTACT

503) 494-6400; hayeslam@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedics and Rehabilitation

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share