The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement: a Randomized, Double-blind, Controlled Trial

Xijing Hospital1 site in 1 country150 target enrollmentApril 2014

ConditionsBlood Loss

InterventionsTranexamic acid

DrugsTranexamic acid

Overview

Phase: Phase 4
Intervention: Tranexamic acid
Conditions: Blood Loss
Sponsor: Xijing Hospital
Enrollment: 150
Locations: 1
Primary Endpoint: Average amounts of transfusion
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

A randomized, double-blind, single-center, controlled and parallel-assigned study comparing the efficacy and safety of intravenous, intra-articular and combinational administration of tranexamic acid to reduce blood loss during total knee replacement. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 3 months postoperatively.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

December 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xijing Hospital

Responsible Party

Principal Investigator

Chenxiaoyong

Doctor-in-charge

Xijing Hospital

Eligibility 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 \[\>1.4 times normal\]).