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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Receving TXA, Study group

Tranexamic acid, Study group tranexamic acid 1g, intravenous injection, pre-operationally

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision

Normal saline, Control group

Not receiving tranexamic acid, Control group Normal saline 100mL, intravenous injection, pre-operationally

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

100 mL of normal saline intravenously approximately 15 minutes before incision

Interventions

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Tranexamic Acid

1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision

Intervention Type DRUG

Normal saline

100 mL of normal saline intravenously approximately 15 minutes before incision

Intervention Type DRUG

Eligibility Criteria

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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 \[\>1.4 times normal\]).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No