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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02286973
Collaborator
(none)
264
Enrollment
4
Arms
7
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic Acid
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
264 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty: Is it the Most Effective Regime? A Randomized Controlled Trial.
Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Apr 1, 2015
Anticipated Study Completion Date :
Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Hemoglobin [baseline and 5 days]

    Blood loss reduce

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tae Kyun Kim, Director, Clinical Research, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02286973
Other Study ID Numbers:
  • B-1407/257-005
First Posted:
Nov 10, 2014
Last Update Posted:
Nov 10, 2014
Last Verified:
Nov 1, 2014
Keywords provided by Tae Kyun Kim, Director, Clinical Research, Seoul National University Hospital
Tranexamic acid
Additional relevant MeSH terms:
Osteoarthritis
Tranexamic Acid

Study Results

No Results Posted as of Nov 10, 2014