Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty

Comparison of Topical and Intravenous Tranexamic Acid on Blood Loss and Transfusion Rates 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 。

Study Overview

• Status: Completed
• Conditions: Blood Loss
• Intervention / Treatment: Drug: 0.9% sodium chloride; Drug: tranexamic acid; Drug: tranexamic acid

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200001
      • Orthopedic Department of Ruijin hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Consented to join in our project.
2. Adult patients (greater than 18 years old)
3. Patients scheduled for primary unilateral hip arthroplasty Patients for Ruijin hospital, Shanghai, China

Exclusion Criteria:

1. Patients who refuse to sign the Inform Consent
2. Had an allergy to TXA.
3. long-term bed >=3 weeks.
4. Using anticoagulant drugs within a week.
5. 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)
6. Pregnancy
7. Breastfeeding
8. 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: .
10. Been participating or been participated within a year in another clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Group1; 60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the hip cavity for at least 3 minutes before wound closure and then sucked away.	Drug: 0.9% sodium chloride; 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
EXPERIMENTAL: Group2; two-dose intravenous tranexamic acid will be applied as follow: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride),the first dose 15' prior to skin incision and the second dose at 180' after the first dosage.	Drug: tranexamic acid; 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; Drug: tranexamic acid; 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 circuit nurse and the circuit nurse will ask the anesthetist to apply the solution intravenously before tourniquet deflation. The dosage and applying route can also be looked up in doctor's order sheet. 60 Milliliters（ml） by irrigation for 3 minutes before wound closure.; Other Names: Cyclokapron
EXPERIMENTAL: Group 3; 3g Tranexamic Acid diluted to 60 Milliliters（ml） with normal saline (0.9% sodium chloride) will be applied by soaking the hip cavity for at least 3 minutes before wound closure and then sucked away.	Drug: tranexamic acid; 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; Drug: tranexamic acid; 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 circuit nurse and the circuit nurse will ask the anesthetist to apply the solution intravenously before tourniquet deflation. The dosage and applying route can also be looked up in doctor's order sheet. 60 Milliliters（ml） by irrigation for 3 minutes before wound closure.; Other Names: Cyclokapron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Blood Loss（TBL）	Total Blood Loss（TBL） was estimated with equations described by Gross et al.	estimated by an equation at the fifth postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion rates	Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay	from the day of surgery to the day of discharge,an expected average of 7 days
Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism)	Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE)	twelve weeks after surgery
other thromboembolic event	Clinically proven Acute Myocardial Infarction 、 acute kidney infarction or cerebral infarction	twelve weeks after surgery
drainage output	The amount of blood collected by a drain attached to the hip is measured 48 hours after surgery	ti will be recorded at the first day and the second day after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of incision leakage	patients will not be allowed to leave the hospital until the leakage stoped	at the every day until the leakage stop,an expected average of 5 days
Disseminated Intravascular Coagulation（DIC）	include Activated Partial Thromboplastin Time（APTT）；Thrombin Time(TT) Prothrombin Time（PT);International Normalized Ratio(INR);Fibrinogen(FG); Fibrin degradation products(FDPs) D-Dimer	at any day before surgery and the first the fifth day after surgery
ecchymosis area	the investigators use the percentage of body surface area to record this outcome	at the seventh day after surgery
human serum albumin	the investigators record the dosage of the human blood albumin used in each group.	from the day of surgery to the day of discharge,an expected average of 7 days
American Society of Anesthesiologists Physical Status Classification (ASA class)	the investigators record ASA class of every patients in each group.	at the day of surgery

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: December 6, 2014
• First Posted (ESTIMATE): December 9, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 28, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: blood loss; tranexamic acid; intravenous administration; topical administration
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: JTU-GK-010