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NCT Number: NCT02393300

Comparison of Topical Versus Intravenous Tranexamic Acid in TKA

Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate largely without major complications . In addition, many meta-analyses have confirmed these results . However, there is little information about comparison among the different routes of TXA administration in TKA. Therefore, this study has been designed to determine which administration route of TXA is more effective and safety.

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Key information

Conditions

Total Blood Loss Exsanguination Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Orthopedic Department of Ruijin hospital

Shanghai, Shanghai Municipality, 200001, China

About this study

Objectives:To assess the efficacy and safety between the two different applying routes.

Patients in this project will be randomly divided into three groups , one group is a blank group and the rest two receive either the topical or the intravenous form of tranexamic acid during unilateral TKA(total knee arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction events will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient.

All surgery are under general anesthesia, through direct lateral approach with cementless prosthesis.For all patients, the drain tube will be clamped and closed completely for 2 hours; then the clamp will be fully opened.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Consented to join in our project.
  • Adult patients (greater than 18 years old)
  • Patients scheduled for primary unilateral knee arthroplasty

Exclusion criteria

  • Patients who refuse to sign the Inform Consent
  • Had an allergy to TXA.
  • Using anticoagulant drugs within a week.
  • Coagulopathy (preoperative platelet count <150,000/mm3,International Sensitivity Index（INR）>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time >1.4 times longer than normal.
  • Breastfeeding
  • Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; renal dysfunction ( glomerular filtration rate<60); or hepatic disfunction(glutamic-pyruvic transaminase>80 or glutamic oxalacetic transaminase>80).Retinopathy (disturbances of color vision).

9.History of thromboembolic disease

Treatment and study plan

normal saline

Drug

The normal saline solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet.

Other names: 0.9% sodium chloride

Tranexamic Acid

Drug

The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet.

Other names: Cyclokapron

Primary outcomes

  1. Total Blood Loss（TBL）

    Time frame: calculated by an equation at the fifth postoperative day

    Total Blood Loss（TBL） was calculated with equations described by Gross et al.

Secondary outcomes

  1. Transfusion rates

    Time frame: from the day of surgery to the day of discharge,an expected average of 7 days

    Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay

Other outcomes

  1. Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary

    Time frame: twelve weeks after surgery

    Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism

  2. other thromboembolic event

    Time frame: twelve weeks after surgery

    Clinically proven Acute Myocardial Infarction、acute kidney infarction or cerebral infarction

  3. drainage output

    Time frame: it will be recorded at the first day and the second day after surgery

  4. human serum albumin usage

    Time frame: from the day of surgery to the day of discharge,an expected average of 7 days

    the investigators will record the dosage of the human blood albumin used in each patient.

  5. American Society of Anesthesiologists Physical Status Classification (ASA class)

    Time frame: at the day of surgery

  6. Disseminated Intravascular Coagulation（DIC）

    Time frame: at any day before surgery and the first the fifth day after surgery

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Comparison of Topical Versus Intravenous Tranexamic Acid in Primary Total Knee Arthroplasty：A Prospective Randomized Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2015
Registry last updated
Apr 4, 2018

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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