Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement; A Prospective Triple-blinded Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Physiologic saline
- Conditions
- Primary Osteoarthritis of Knee Nos
- Sponsor
- Mahidol University
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- Perioperative Blood Loss
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.
Investigators
Viroj Kawinwonggowit
Clinical Professor
Mahidol University
Eligibility Criteria
Inclusion Criteria
- •patients diagnosed as primary knee osteoarthritis and underwent unilateral primary cemented conventional total knee replacement
- •no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine \< 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days
- •no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria)
Exclusion Criteria
- •incomplete data collection, for example, malfunctioned drain or accidental drain removal.
Arms & Interventions
Control group
physiologic saline 25 ml
Intervention: Physiologic saline
TXA-250 group
A total of 25-ml solution with 250-mg tranexamic acid
Intervention: Tranexamic Acid
TXA-250 group
A total of 25-ml solution with 250-mg tranexamic acid
Intervention: Physiologic saline
TXA-500 group
A total of 25-ml solution with 500-mg tranexamic acid
Intervention: Tranexamic Acid
TXA-500 group
A total of 25-ml solution with 500-mg tranexamic acid
Intervention: Physiologic saline
Outcomes
Primary Outcomes
Perioperative Blood Loss
Time Frame: 5 days after surgery
* Drainage blood loss measured by accumulating total drainage volume postoperatively * Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day
Total Hemoglobin Loss
Time Frame: 5 days after surgery
Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day
Secondary Outcomes
- Knee Function Scores(1 year after surgery)
- Number of Patients Required Blood Transfusion(postoperative period (5 days after surgery))
- Number of Patients Having Postoperative Complications(postoperative 1-year period)