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

Phase 1
Conditions
Degenerative Arthritis
Interventions
Registration Number
NCT02286973
Lead Sponsor
Seoul National University Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
264
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Only Intravenous GroupTranexamic AcidOnly Intravenous Injection During Operation, 10mg/kr
Intravenous + Topical 1g GroupTranexamic AcidIntravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 1g
Intravenous + Topical 2g GroupTranexamic AcidIntravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 2g
No Intravenous, Only Topical 2g GroupTranexamic AcidOnly Topical Injection 2g
Primary Outcome Measures
NameTimeMethod
Change in Hemoglobinbaseline and 5 days

Blood loss reduce

Secondary Outcome Measures
NameTimeMethod
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