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

November 7, 2014 updated by: Tae Kyun Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: TaeKyun Kim, MD,PhD
  • Phone Number: 082-031-787-3355
  • Email: osktk@gmail.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Only Intravenous Group
Only Intravenous Injection During Operation, 10mg/kr
Drug: Tranexamic Acid
Active Comparator: Intravenous + Topical 1g Group

Intravenous Injection During Operation, 10mg/kr

After Capsule Closure, Tranexamic acid Topical Injection 1g
Drug: Tranexamic Acid
Active Comparator: Intravenous + Topical 2g Group

Intravenous Injection During Operation, 10mg/kr

After Capsule Closure, Tranexamic acid Topical Injection 2g
Drug: Tranexamic Acid
Active Comparator: No Intravenous, Only Topical 2g Group
Only Topical Injection 2g
Drug: Tranexamic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin
Time Frame: baseline and 5 days
Blood loss reduce
baseline and 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

October 27, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Estimate)

November 10, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1407/257-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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