Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty

Seoul National University

Status and phase: Unknown; Phase 1

Conditions: Degenerative Arthritis

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02286973

B-1407/257-005

Details and patient eligibility

About

This prospective randomized controlled trial was conducted To compare the efficacy of TNA in terms of total blood loss and the allogenic transfusion rate among the three study groups; intravenous alone, combined intravenous and low dose topical TNA and combined intravenous and high dose topical TNA.

To evaluate the safety of each regimen in view of deep vein thrombosis and venous thromboembolism.

Enrollment: 264 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients with diagnosis of primary osteoarthritis

Exclusion criteria

• patients with diagnoses other than primary OA
• patients on anticoagulation therapy
• patient with chronic renal failure
• patient with CVA Hx
• Patient with seizure Hx
• Patient with severe CHF
• Patient with acquired or congenital coagulopathy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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264 participants in 4 patient groups

Only Intravenous Group

Active Comparator group

Description:

Only Intravenous Injection During Operation, 10mg/kr

Treatment:

Drug: Tranexamic Acid

Intravenous + Topical 1g Group

Active Comparator group

Description:

Intravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 1g

Treatment:

Drug: Tranexamic Acid

Intravenous + Topical 2g Group

Active Comparator group

Description:

Intravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 2g

Treatment:

Drug: Tranexamic Acid

No Intravenous, Only Topical 2g Group

Active Comparator group

Description:

Only Topical Injection 2g

Treatment:

Drug: Tranexamic Acid