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Comparison Between Low Dose and High Dose Intra-articular Tranexamic Acid in Total Knee Arthroplasty

Primary Purpose

Blood Loss, Surgical

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss, Surgical focused on measuring Blood loss, Tranexamic acid, Total knee arthroplasty, Topical administration

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Osteoarthritic knee who underwent primary total knee arthroplasty

Exclusion Criteria:

  • Abnormal coagulation or bleeding disorder
  • Allergy to tranexamic acid
  • History of thromboembolism or ischemic heart disease or cerebrovascular accident
  • chronic kidney disease stage 3-4

Sites / Locations

  • Thammasat University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low dose

High dose

Arm Description

single dose of intra-articular Tranexamic acid 500 miligrams

Single dose of intra-articular Tranexamic acid 3 grams

Outcomes

Primary Outcome Measures

Total blood loss
Blood loos that calculated from Haemoglobin drop at 72 hours after surgery

Secondary Outcome Measures

Blood transfusion
incidence of blood transfusion after surgery
Rate of participants with thromboembolism
Clinical thromboembolism after surgery
Rate of participants with infection
Superficial or deep infection after TKA
Knee ROM
Range of motion of the knee
Functional score
Modified WOMAC

Full Information

First Posted
January 29, 2017
Last Updated
January 27, 2018
Sponsor
Thammasat University
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1. Study Identification

Unique Protocol Identification Number
NCT03044041
Brief Title
Comparison Between Low Dose and High Dose Intra-articular Tranexamic Acid in Total Knee Arthroplasty
Official Title
Topical Intra-Articular High Doses Compared With Low Doses of Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare blood loss between using low dose (500 mg) and high dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in double-blind RCT

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
Keywords
Blood loss, Tranexamic acid, Total knee arthroplasty, Topical administration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Description
single dose of intra-articular Tranexamic acid 500 miligrams
Arm Title
High dose
Arm Type
Active Comparator
Arm Description
Single dose of intra-articular Tranexamic acid 3 grams
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
IA (intra-articular) tranexamic acid after capsule closure
Primary Outcome Measure Information:
Title
Total blood loss
Description
Blood loos that calculated from Haemoglobin drop at 72 hours after surgery
Time Frame
72 hours after TKA
Secondary Outcome Measure Information:
Title
Blood transfusion
Description
incidence of blood transfusion after surgery
Time Frame
0-72 hours after surgery
Title
Rate of participants with thromboembolism
Description
Clinical thromboembolism after surgery
Time Frame
At 72 hours and 2 weeks after surgery
Title
Rate of participants with infection
Description
Superficial or deep infection after TKA
Time Frame
0-3 months after surgery
Title
Knee ROM
Description
Range of motion of the knee
Time Frame
At 2, 6 weeks after surgery
Title
Functional score
Description
Modified WOMAC
Time Frame
At 6 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Osteoarthritic knee who underwent primary total knee arthroplasty Exclusion Criteria: Abnormal coagulation or bleeding disorder Allergy to tranexamic acid History of thromboembolism or ischemic heart disease or cerebrovascular accident chronic kidney disease stage 3-4
Facility Information:
Facility Name
Thammasat University
City
Klong Luang
State/Province
Pathum Thani
ZIP/Postal Code
12120
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparison Between Low Dose and High Dose Intra-articular Tranexamic Acid in Total Knee Arthroplasty

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