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

Phase 4

Completed

• Conditions: Blood Loss
• Interventions: Drug: Normal saline; Drug: Tranexamic Acid

• Registration Number: NCT02504125
• Lead Sponsor: Xijing Hospital

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 Timeline

• Study Start: 2013-01
• Primary Completion: 2014-06
• Study Completion: 2015-06
• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-07-19
• Study First Posted: 2015-07-21
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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]).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline, Control group	Normal saline	Not receiving tranexamic acid, Control group Normal saline 100mL, intravenous injection, pre-operationally
Receving TXA, Study group	Tranexamic Acid	Tranexamic acid, Study group tranexamic acid 1g, intravenous injection, pre-operationally

Primary Outcome Measures

Name	Time	Method
Rate of Allogeneic Blood Transfusion as a Measure of Efficacy	one week after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China