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NCT Number: NCT02312440

Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty

Recently, there has been interest in applying tranexamic acid topically before the closure of surgical wounds in total hip replacement. It has the advantages of ease of application, maximum concentration at the site of bleeding, minimising its systematic absorption and, potentially , decline the risks for systematic side-effects 。

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Key information

Conditions

Blood Loss 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 are randomly divided into three groups , one group is a blank group and the rest two groups receive either the topical or the intravenous form of tranexamic acid during unilateral THA(total hip arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while the events of Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction 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 is clamped and closed completely for 2 hours; then the clamp is 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 hip arthroplasty Patients for Ruijin hospital, Shanghai, China

Exclusion criteria

  • Patients who refuse to sign the Inform Consent
  • Had an allergy to TXA.
  • long-term bed >=3 weeks.
  • Using anticoagulant drugs within a week.
  • Coagulopathy (preoperative platelet count <150,000/mm3, INR>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time (>1.4 times longer than normal)
  • Pregnancy
  • 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).
  • History of thromboembolic disease: .
  • Been participating or been participated within a year in another clinical trial

Treatment and study plan

0.9% Sodium Chloride

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: normal saline

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: estimated by an equation at the fifth postoperative day

    Total Blood Loss（TBL） was estimated 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

  2. Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism)

    Time frame: twelve weeks after surgery

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

  3. other thromboembolic event

    Time frame: twelve weeks after surgery

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

  4. drainage output

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

    The amount of blood collected by a drain attached to the hip is measured 48 hours after surgery

Other outcomes

  1. length of incision leakage

    Time frame: at the every day until the leakage stop,an expected average of 5 days

    patients will not be allowed to leave the hospital until the leakage stoped

  2. Disseminated Intravascular Coagulation（DIC）

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

    include Activated Partial Thromboplastin Time（APTT）；Thrombin Time(TT) Prothrombin Time（PT);International Normalized Ratio(INR);Fibrinogen(FG); Fibrin degradation products(FDPs) D-Dimer

  3. ecchymosis area

    Time frame: at the seventh day after surgery

    the investigators use the percentage of body surface area to record this outcome

  4. human serum albumin

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

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

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

    Time frame: at the day of surgery

    the investigators record ASA class of every patients in each group.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Comparison of Topical and Intravenous Tranexamic Acid on Blood Loss and Transfusion Rates in Total Hip Arthroplasty

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2014
Registry last updated
Dec 2, 2015

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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