search
Back to results

Comparison of Topical Versus Intravenous Tranexamic Acid in TKA

Primary Purpose

Total Blood Loss

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
normal saline
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 Total 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 knee arthroplasty

Exclusion Criteria:

  1. Patients who refuse to sign the Inform Consent
  2. Had an allergy to TXA.
  3. Using anticoagulant drugs within a week.
  4. 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.
  5. Breastfeeding
  6. 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

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 knee 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' before the tourniquet deflation 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 knee 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 calculated 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

Full Information

First Posted
March 15, 2015
Last Updated
April 3, 2018
Sponsor
Shanghai Jiao Tong University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT02393300
Brief Title
Comparison of Topical Versus Intravenous Tranexamic Acid in TKA
Official Title
Comparison of Topical Versus Intravenous Tranexamic Acid in Primary Total Knee Arthroplasty：A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
October 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
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total 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 ProviderInvestigator
Allocation
Randomized
Enrollment
174 (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 knee 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' before the tourniquet deflation 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 knee cavity for at least 3 minutes before wound closure and then sucked away.
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
0.9% sodium chloride
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.
Primary Outcome Measure Information:
Title
Total Blood Loss（TBL）
Description
Total Blood Loss（TBL） was calculated with equations described by Gross et al.
Time Frame
calculated 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
Other Pre-specified Outcome Measures:
Title
Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary
Description
Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism
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
Time Frame
it will be recorded at the first day and the second day after surgery
Title
human serum albumin usage
Description
the investigators will record the dosage of the human blood albumin used in each patient.
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)
Time Frame
at the day of surgery
Title
Disseminated Intravascular Coagulation（DIC）
Time Frame
at any day before surgery and the first the fifth day after 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 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
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

Learn more about this trial

Comparison of Topical Versus Intravenous Tranexamic Acid in TKA

We'll reach out to this number within 24 hrs