Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement

Mahidol University

Status: Completed

Conditions: Primary Osteoarthritis of Knee Nos

Treatments: Drug: Tranexamic Acid; Drug: Physiologic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01850394

ID 01-53-06

Details and patient eligibility

About

The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.

Enrollment: 152 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients diagnosed as primary knee osteoarthritis and underwent unilateral primary cemented conventional total knee replacement
• no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine < 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days
• no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria)

Exclusion criteria

• incomplete data collection, for example, malfunctioned drain or accidental drain removal.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

physiologic saline 25 ml

Treatment:

Drug: Physiologic saline

TXA-250 group

Active Comparator group

Description:

A total of 25-ml solution with 250-mg tranexamic acid

Treatment:

Drug: Tranexamic Acid

Drug: Physiologic saline

TXA-500 group

Active Comparator group

Description:

A total of 25-ml solution with 500-mg tranexamic acid

Treatment:

Drug: Tranexamic Acid

Drug: Physiologic saline