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

NCT ID: NCT02286973

Last Updated: 2014-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Degenerative Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Only Intravenous Group

Only Intravenous Injection During Operation, 10mg/kr

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

Intravenous + Topical 1g Group

Intravenous Injection During Operation, 10mg/kr

After Capsule Closure, Tranexamic acid Topical Injection 1g

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

Intravenous + Topical 2g Group

Intravenous Injection During Operation, 10mg/kr

After Capsule Closure, Tranexamic acid Topical Injection 2g

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

No Intravenous, Only Topical 2g Group

Only Topical Injection 2g

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

Interventions

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Tranexamic Acid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tae Kyun Kim

Director, Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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TaeKyun Kim, MD,PhD

Role: CONTACT

[email protected]
082-031-787-3355

Sungyup Lee, MD

Role: CONTACT

[email protected]
082-031-787-6480

Other Identifiers

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B-1407/257-005

Identifier Type: -

Identifier Source: org_study_id