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

T

Thammasat University

Status and phase

Completed
Phase 4

Conditions

Blood Loss, Surgical

Treatments

Drug: Tranexamic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT03044041
OrthoTU08

Details and patient eligibility

About

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

Enrollment

80 estimated patients

Sex

All

Ages

50 to 90 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

Low dose
Experimental group
Description:
single dose of intra-articular Tranexamic acid 500 miligrams
Treatment:
Drug: Tranexamic Acid
High dose
Active Comparator group
Description:
Single dose of intra-articular Tranexamic acid 3 grams
Treatment:
Drug: Tranexamic Acid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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