Not yet recruiting NCT06832878
Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral Tranexamic Acid.
- Who it may be relevant to
- Registry conditions: Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to evaluate the impact of an extended oral Tranexamic Acid regimen on patient reported outcome scores, time to independent ambulation, postoperative range of motion, swelling, change in hemoglobin levels, 90-day complications, readmission and reoperation.
Interventions
- Drug Oral Tranexamic Acid
Subjects will receive a 1.95 g dose of oral TXA at the following timepoints: (1) following ambulation, (2) postoperative day 1, (3) postoperative day 2, and (4) postoperative day 3
Primary outcome measures
- Visual Analog Score [Time frame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks]
- Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR) [Time frame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks]
Secondary outcome measures (5)
- Hemoglobin [Time frame: Baseline, prior to discharge, day 3 postoperatively]
- Harris Hip Score (HHS) [Time frame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks]
- Short Form Health Survey (SF-12) [Time frame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks]
- Time to Independent Ambulation [Time frame: 12 weeks]
- Oxford Hip Score [Time frame: Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks]
Eligibility criteria
Inclusion criteria
- Adults aged > 18 years (All women of childbearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
- Written informed consent
- Patients undergoing primary THA diagnosis of end-stage osteoarthritis
- Patients receiving spinal anesthesia
- Patients being discharged on postoperative day 1
Exclusion criteria
- Patients with a TXA allergy
- Patients undergoing revision procedures
- Patients undergoing primary THA for a diagnosis other than end-stage osteoarthritis
- Patients receiving general anesthesia
- Patients being discharged on the same day of surgery
- Cancer patients
- Patients with a history of prior VTE event
- Patients on preoperative anticoagulants other than ASA
- Pregnant patients (All women of child bearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
- Female patients who are on hormonal contraception
- Patients with history of retinal vein or artery occlusion
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Arizona — Scottsdale
Identifiers
NCT: NCT06832878 · 24-008865