Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty
1 other identifier
interventional
264
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2014
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedFirst Posted
Study publicly available on registry
November 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 10, 2014
November 1, 2014
5 months
October 27, 2014
November 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hemoglobin
Blood loss reduce
baseline and 5 days
Study Arms (4)
Only Intravenous Group
ACTIVE COMPARATOROnly Intravenous Injection During Operation, 10mg/kr
Intravenous + Topical 1g Group
ACTIVE COMPARATORIntravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 1g
Intravenous + Topical 2g Group
ACTIVE COMPARATORIntravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 2g
No Intravenous, Only Topical 2g Group
ACTIVE COMPARATOROnly Topical Injection 2g
Interventions
Eligibility Criteria
You may qualify if:
- patients with diagnosis of primary osteoarthritis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Clinical Research
Study Record Dates
First Submitted
October 27, 2014
First Posted
November 10, 2014
Study Start
November 1, 2014
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
November 10, 2014
Record last verified: 2014-11