Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty
NCT ID: NCT02152917
Last Updated: 2014-06-02
Study Results
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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UNKNOWN
PHASE4
45 participants
INTERVENTIONAL
2014-02-28
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tranexamic acid
A dose of tranexamic acid (10mg/Kg) will be administered 20 minutes before inflating the pneumatic tourniquet and another dose 15 minutes after the tourniquet release.
Tranexamic acid
Floseal®
Floseal® will be applied in regions of potential bleeding before the release of the pneumatic tourniquet.
Floseal®
Control group
No interventions assigned to this group
Interventions
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Tranexamic acid
Floseal®
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No previous knee surgery
* Absence of inflammatory arthritis
* Absence of stiff knee
* Absence of the following factors: renal failure, liver failure, severe heart failure, respiratory failure, history of thromboembolic events, bleeding disorders, previous strokes
Exclusion Criteria
21 Years
ALL
Yes
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Marco Kawamura Demange
Assistant Professor
Principal Investigators
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Camilo P Helito, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Ricardo G Gobbi, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Luis Eduardo P Tirico, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Marco K Demange, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Jose R Pecora, Ph.D.
Role: STUDY_DIRECTOR
University of Sao Paulo
Gilberto L Camanho, Ph.D.
Role: STUDY_CHAIR
University of Sao Paulo
Marcelo B Bonadio, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Hospital das Clinicas - University of Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Helito CP, Bonadio MB, Sobrado MF, Giglio PN, Pecora JR, Camanho GL, Demange MK. Comparison of Floseal(R) and Tranexamic Acid for Bleeding Control after Total Knee Arthroplasty: a Prospective Randomized Study. Clinics (Sao Paulo). 2019 Nov 25;74:e1186. doi: 10.6061/clinics/2019/e1186. eCollection 2019.
Other Identifiers
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2014/11297
Identifier Type: -
Identifier Source: org_study_id
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