Primary osteoarthritis of knee Osteoarthritis knee Total knee arthroplasty Oral Tranexamic acid Total postoperative blood loss Randomized controlled trial
Conditions
Interventions
Oral tranexamic acid 30 mg per kg per day with a maximum dose of 2 g per day administered for 3 days after primary total knee arthroplasty,Oral tranexamic acid 15 mg per kg per day with a maximum dose
Experimental Drug,Active Comparator Drug
High Dose Oral Tranexamic Acid,Low Dose Oral Tranexamic Acid
Sponsors
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients with primary knee osteoarthritis undergoing unilateral primary total knee arthroplasty at Department of Orthopedics Faculty of Medicine Vajira Hospital Navamindradhiraj University 2.Age 45 to 80 years 3.ASA physical status 1 to 3 4.Written informed consent obtained
Exclusion criteria
Exclusion criteria: 1.Inflammatory knee disease or chronic knee pain unrelated to osteoarthritis 2.Renal impairment with eGFR less than 30 mL per min per 1.73 m2 or serum creatinine greater than 1.5 mg per dL 3.History of venous thromboembolism 4.History of subarachnoid hemorrhage 5.History of malignancy 6.Known allergy to tranexamic acid 7.Use of anticoagulant drugs other than aspirin 8.Severe psychiatric illness 9.Pregnancy 10.Use of prothrombotic medications including hormonal therapy or erythropoiesis stimulating agents 11.Gastrointestinal disorders affecting oral drug absorption or previous major gastrointestinal surgery 12.Use of medications with significant interaction with tranexamic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total blood loss following primary total knee arthroplasty Postoperative day 3 Gross Formula based on preoperative and postoperative hematocrit levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified WOMAC Score POD 14, 6 Week , 3Month Modified WOMAC questionnaire assessing pain, stiffness, and physical function,Knee circumference POD 14, 6 Week , 3Month Measured at the mid-patellar level using a measuring tape with the knee in full extension; reported in centimeters (cm),VAS pain score POD 14, 6 Week , 3Month Patient reported pain intensity using a Visual Analog Scale,Knee Range of Motion POD 14, 6 Week , 3Month Knee range of motion will be measured using a goniometer with the patient in the supine position. Maximum knee flexion and knee extension angles will be recorded and reported in degrees,Persistent wound drainage Within 14 days after surgery Presence of wound drainage persisting for more than 5 days after surgery,Superficial wound infection Within 90 days after surgery Diagnosed according to CDC criteria for superficial surgical site infection,Venous thromboembolic events Within 90 days after surgery DVT confirmed by Duplex Doppler Ultrasonography and PE confirmed by CTPA | — |
Countries
Thailand
Contacts
Public ContactSeksiri Pragobpanich
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Outcome results
None listed