N/A
Completed N=135
Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement
Primary Osteoarthritis of Knee Nos
Source: ClinicalTrials.gov NCT01850394 ↗
Enrolled (actual)
135
Serious AEs
5.2%
Results posted
Dec 2013
Primary outcomePrimary: Perioperative Blood Loss — 546.9; 475.0; 430.2; 329.2 ml — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perioperative Blood Loss |
546.9; 475.0; 430.2; 329.2; 239.7; 217.2 | <0.05 sig |
| PRIMARY Total Hemoglobin Loss |
2.9; 2.2; 2.2 | 0.05 |
| SECONDARY Knee Function Scores |
148.9; 151.2; 150.9; 15.5; 15.1; 14.5 | <0.05 sig |
| SECONDARY Number of Patients Required Blood Transfusion |
10; 6; 0 | <0.05 sig |
| SECONDARY Number of Patients Having Postoperative Complications |
6; 1; 0; 3; 0; 0 | <0.05 sig |
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.
Data sourced from ClinicalTrials.gov (NCT01850394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.