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Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty

Primary Purpose

Blood Loss

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
0.9% sodium chloride
tranexamic acid
tranexamic acid
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss focused on measuring tranexamic acid, blood loss, topical administration, intravenous administration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopedic Department of Ruijin hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Group1

Group2

Group 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Transfusion rates
Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay
Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism)
Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE)
other thromboembolic event
Clinically proven Acute Myocardial Infarction 、 acute kidney infarction or cerebral infarction
drainage output
The amount of blood collected by a drain attached to the hip is measured 48 hours after surgery

Full Information

First Posted
November 10, 2014
Last Updated
November 28, 2015
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02312440
Brief Title
Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty
Official Title
Comparison of Topical and Intravenous Tranexamic Acid on Blood Loss and Transfusion Rates in Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 。
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
tranexamic acid, blood loss, topical administration, intravenous administration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group1
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Group2
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride
Other Intervention Name(s)
normal saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
tranexamic acid
Other Intervention Name(s)
Cyclokapron
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
tranexamic acid
Other Intervention Name(s)
Cyclokapron
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Blood Loss（TBL）
Description
Total Blood Loss（TBL） was estimated with equations described by Gross et al.
Time Frame
estimated by an equation at the fifth postoperative day
Secondary Outcome Measure Information:
Title
Transfusion rates
Description
Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay
Time Frame
from the day of surgery to the day of discharge,an expected average of 7 days
Title
Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism)
Description
Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE)
Time Frame
twelve weeks after surgery
Title
other thromboembolic event
Description
Clinically proven Acute Myocardial Infarction 、 acute kidney infarction or cerebral infarction
Time Frame
twelve weeks after surgery
Title
drainage output
Description
The amount of blood collected by a drain attached to the hip is measured 48 hours after surgery
Time Frame
ti will be recorded at the first day and the second day after surgery
Other Pre-specified Outcome Measures:
Title
length of incision leakage
Description
patients will not be allowed to leave the hospital until the leakage stoped
Time Frame
at the every day until the leakage stop,an expected average of 5 days
Title
Disseminated Intravascular Coagulation（DIC）
Description
include Activated Partial Thromboplastin Time（APTT）；Thrombin Time(TT) Prothrombin Time（PT);International Normalized Ratio(INR);Fibrinogen(FG); Fibrin degradation products(FDPs) D-Dimer
Time Frame
at any day before surgery and the first the fifth day after surgery
Title
ecchymosis area
Description
the investigators use the percentage of body surface area to record this outcome
Time Frame
at the seventh day after surgery
Title
human serum albumin
Description
the investigators record the dosage of the human blood albumin used in each group.
Time Frame
from the day of surgery to the day of discharge,an expected average of 7 days
Title
American Society of Anesthesiologists Physical Status Classification (ASA class)
Description
the investigators record ASA class of every patients in each group.
Time Frame
at the day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jianmin feng, master
Organizational Affiliation
ruijin hospital，shanghai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Department of Ruijin hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China

12. IPD Sharing Statement

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Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty

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