The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

We will investigate the efficacy and safety of using tranexamic acid by intravenous, intra-articular and combinational administration to reduce blood loss during total knee replacement. We hypothesize a combined intra-articular and single intravenous dose protocol of tranexamic acid may achieve a higher therapeutic concentration at the intra-articular and extra-articular bleeding site with little or no systemic absorption and subsequent systemic side effects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Adult patients who plan to undergo primary total knee arthroplasty on unilateral 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]).