Blood Loss
Conditions
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.
Interventions
DRUGTranexamic Acid
1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision
DRUGNormal saline
100 mL of normal saline intravenously approximately 15 minutes before incision
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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 \[\>1.4 times normal\]).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Allogeneic Blood Transfusion as a Measure of Efficacy | one week after surgery |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed