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Clinical Trials/NCT03044041
NCT03044041CompletedPhase 4

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

Thammasat University1 site in 1 country80 target enrollmentStarted: January 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
Total blood loss
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Low dose

Experimental

single dose of intra-articular Tranexamic acid 500 miligrams

Intervention: Tranexamic Acid (Drug)

High dose

Active Comparator

Single dose of intra-articular Tranexamic acid 3 grams

Intervention: Tranexamic Acid (Drug)

Outcomes

Primary Outcomes

Total blood loss

Time Frame: 72 hours after TKA

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

Secondary Outcomes

  • Functional score(At 6 weeks after surgery)
  • Rate of participants with infection(0-3 months after surgery)
  • Blood transfusion(0-72 hours after surgery)
  • Rate of participants with thromboembolism(At 72 hours and 2 weeks after surgery)
  • Knee ROM(At 2, 6 weeks after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Supakit Kanitnate

Investigator

Thammasat University

Study Sites (1)

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