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

Air Force Military Medical University of People's Liberation Army

Status and phase

Completed

Phase 4

Conditions

Blood Loss

Treatments

Drug: Tranexamic Acid

Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02504125

XJODCT2014002

Details and patient eligibility

About

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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]).