The Efficacy and Safety of Using Tranexamic Acid to Reduce Blood Loss In Simultaneous Bilateral Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty.

Detailed Description
-----------------
A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 1 months postoperatively.

Official Title
-----------------
The Efficacy and Safety of Using Tranexamic Acid to Reduce Blood Loss In Simultaneous Bilateral Total Knee Arthroplasty: a Randomized, Double-blind, Controlled Trial

Conditions
-----------------
Blood Loss

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients who plan to undergo simultaneous primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or aseptic bone necrosis, but not of rheumatoid arthritis; All patients who have normal preoperative platelet count, normal prothrombin time, normal partial thromboplastin time, and normal international normalized ratio; The use of only balanced electrolyte solutions and/or albumin for plasma volume restitution Exclusion Criteria: Allergy to tranexamic acid; Receiving warfarin or heparin; had a history of hemophilia, deep venous thrombosis, pulmonary embolism, or renal impairment; or were pregnant; Patients with any cardiovascular problems (such as myocardiac infarction history, atrial fibrillation, angina); Patients with thromboembolic disorders, or those exhibiting a deteriorating general condition; Preoperative anemia (a hemoglobin value of <11 g/dL in females and <12 g/dL in males), refusal of blood products; Preoperative use of anticoagulant therapy within five days before surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy (as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.4, or a prolonged partial thromboplastin time [>1.4 times normal]).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receving TXA, Study group<br>Tranexamic acid, Study group tranexamic acid 1g, intravenous injection, pre-operationally | Drug: Tranexamic Acid<br>* 1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision<br>|
| Placebo Comparator: Normal saline, Control group<br>Not receiving tranexamic acid, Control group Normal saline 100mL, intravenous injection, pre-operationally | Drug: Normal saline<br>* 100 mL of normal saline intravenously approximately 15 minutes before incision<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Allogeneic Blood Transfusion as a Measure of Efficacy |  | one week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Total Blood Loss as a Measure of Efficacy |  | one week after surgery | 
| Rate of Thrombotic Complications as a Measure of Safety |  | 1 months after surgery |