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Completed

NCT Number: NCT02504125

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xijing hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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]).

Treatment and study plan

Tranexamic Acid

Drug

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

normal saline

Drug

100 mL of normal saline intravenously approximately 15 minutes before incision

Primary outcomes

  1. Rate of Allogeneic Blood Transfusion as a Measure of Efficacy

    Time frame: one week after surgery

Secondary outcomes

  1. Amount of Total Blood Loss as a Measure of Efficacy

    Time frame: one week after surgery

  2. Rate of Thrombotic Complications as a Measure of Safety

    Time frame: 1 months after surgery

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

The Efficacy and Safety of Using Tranexamic Acid to Reduce Blood Loss In Simultaneous Bilateral Total Knee Arthroplasty: a Randomized, Double-blind, Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 21, 2015
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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