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

Degenerative Arthritis Clinical Trial

Official title:

Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty: Is it the Most Effective Regime? A Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02286973
• Other study ID #: B-1407/257-005
• Status: Not yet recruiting
• Phase: Phase 1
• First received: October 27, 2014
• Last updated: November 7, 2014
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2014
• Source: Seoul National University Hospital
• Contact: TaeKyun Kim, MD,PhD
• Phone: 082-031-787-3355
• Email: osktk[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 264
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Degenerative Arthritis
• Osteoarthritis

Intervention

Drug:
• Tranexamic Acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin	Blood loss reduce	baseline and 5 days	Yes