Knee Osteoarthritis
Conditions
Keywords
total knee replacement arthroplasty, total knee arthroplasty, tranexamic acid, oral tranexamic acid, transfusion, blood loss
Brief 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.
Detailed description
It has been demonstrated that tranexamic acid (TXA) reduces the peri-operative blood loss as well as the need for transfusion in total knee replacement arthroplasty(TKRA). The anti-fibrinolytic effects of TXA have been shown to mainly present in the wound that, in previous studies, the use of TXA decreased the blood loss without increasing the risk of thromboembolic complications. Nevertheless, the optimal dose, duration of treatment and route of administration of TXA to reduce blood loss while minimizing adverse effects remain uncertain. To use TXA as a pharmacologic alternative to transfusion, optimal regimen should be elucidated. Various studies have reported the effect of perioperative use of intravenous or topical TXA. Meta-analyses concluded that combined use of intravenous and topical TXA is more effective in reducing the blood loss and transfusion rate without increasing the risk of deep vein thrombosis or pulmonary embolism compared to the use of either intravenous TXA or topical TXA alone. Both intravenous and topical administration was conducted pre or intraoperatively or within 6 hours post-operatively mainly due to conceivable risk of thromboembolic event when TXA is used continuously after surgery. However, regarding the fact that systemic activation of fibrinolysis starts post-operatively in TKRA using tourniquets and lasts over 18 hours, the continuous use of TXA after surgery might have additional benefit over the single day use. Moreover, the serial use of post-operative oral TXA for 5 days after perioperative IV TXA use has been shown to significantly reduce transfusion rate without increasing thromboembolic complications compared to placebo. Therefore, in this study, the investigators aimed to 1) investigate the effect of serial use of perioperative IV and post-operative oral TXA in reducing the blood loss and transfusion risk compared to single day perioperative use of IV TXA and 2) assess the sufficient length of postoperative use of oral TXA in TKRA patients.
Interventions
DRUGTranexamic Acid
On the day of operation, same dose of IV tranexamic acid(TXA) is given to all subjects in three study groups. Oral TXA is given from postoperative day 1 only to experimental groups. Duration of oral TXA administration is different between two experimental groups. (5 days in IV TXA and Oral TXA 5 days group and 2 days in IV TXA and Oral TXA 2 days group)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from preoperative hemoglobin at day 2 | Preop. day 1 to postop. day 2 | Hemoglobin (g/dL) |
| Change from preoperative hemoglobin at day 6 | Preop. day 1 to postop. day 6 | Hemoglobin (g/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transfusion rate and amount | Postoperative day 0 to day 6 | transfusion trigger: packed red blood cell(RBC) 1 pack is given if Hb \< 7 or 7 ≤ Hb\< 8 with symptom of anemia |
| Complications | up to 6 week after operation | CT angiography on postoperative day 6 for evaluation of deep vein thrombosis, Pulmonary embolism, superficial or deep infection, and other complications are assessed clinically. |
| Calculated Blood loss | Postop. day 6 | Based on predicted blood volume and hemoglobin balance |
Countries
South Korea
Contacts
Primary ContactSeung-Baik Kang, MD, PhD
Backup ContactChan Yoon, MD
Outcome results
None listed