The Efficacy and Safety of Using Tranexamic Acid to Reduce Blood Loss In Simultaneous Bilateral Total Knee Arthroplasty: a Randomized, Double-blind, Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Rate of Allogeneic Blood Transfusion as a Measure of Efficacy
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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]).
Arms & Interventions
Receving TXA, Study group
Tranexamic acid, Study group tranexamic acid 1g, intravenous injection, pre-operationally
Intervention: Tranexamic Acid (Drug)
Normal saline, Control group
Not receiving tranexamic acid, Control group Normal saline 100mL, intravenous injection, pre-operationally
Intervention: Normal saline (Drug)
Outcomes
Primary Outcomes
Rate of Allogeneic Blood Transfusion as a Measure of Efficacy
Time Frame: one week after surgery
Secondary Outcomes
- Rate of Thrombotic Complications as a Measure of Safety(1 months after surgery)
- Amount of Total Blood Loss as a Measure of Efficacy(one week after surgery)
Investigators
Chenxiaoyong
Doctor-in-charge
Xijing Hospital