Serial Use of Intravenous and Oral Tranexamic Acid in Primary Total Knee Arthroplasty Patients

• Status: Unknown status
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The usefulness of tranexamic acid(TXA) to reduce blood loss and transfusion in total knee replacement arthroplasty(TKRA) has been demonstrated. However, the optimal does, duration of treatment and route of administration of TXA to reduce blood loss while minimizing adverse effects remain uncertain. Recently, the serial use of perioperative IV and post-operative oral TXA has been shown to significantly reduce transfusion rate without increasing thromboembolic complications compared to placebo. The aim of this study is to 1) determine the beneficial effect and safety of the serial treatment of IV and oral TXA over IV use alone and 2) assess the sufficient length of postoperative use of oral TXA in TKRA patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Candidate for total knee replacement arthroplasty due to osteoarthritis of the knee.

Exclusion Criteria:

• Known allergic reaction to tranexamic acid

• Secondary arthritis (ex. Rheumatic arthritis, traumatic arthritis, septic arthritis)

• History of thromboembolic event including deep vein thrombosis, pulmonary embolism, cerebral infarction, transient ischemic attack, myocardial infarction, angina

• Premenopausal female

• Known congenital or acquired coagulopathy

• Currently in treatment with Adenosine disphosphate receptor inhibitors, Vitamin K antagonist, Factor Xa inhibitor, Direct thrombin inhibitor or Heparin

• Aspirin administration within 5 days before operation

• Preoperative Prothrombin time(PT) international normalized ratio(INR) > 1.4

• Severe systemic comorbidities of American Society of Anesthesiology (ASA) grade 4 including heart failure, renal failure, hepatic failure, pulmonary disease and cancer

• Do not agree to participate in the study