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Completed

NCT Number: NCT02117128

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

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.

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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, 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.

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 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]).

Treatment and study plan

Tranexamic Acid

Drug

Primary outcomes

  1. Average amounts of transfusion

    Time frame: one week after surgery

Secondary outcomes

  1. Calculated blood loss

    Time frame: one week after surgery

  2. thrombosis

    Time frame: 3 months after surgery

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2014
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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