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Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty

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Mayo Clinic

Status and phase

Begins enrollment in 3 months
Phase 4

Conditions

Arthroplasty

Treatments

Drug: Oral Tranexamic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT06832878
24-008865

Details and patient eligibility

About

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.

Enrollment

101 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

101 participants in 2 patient groups

Oral tranexamic acid
Experimental group
Treatment:
Drug: Oral Tranexamic Acid
Control Group
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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