Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty
May 30, 2014 updated by: Marco Kawamura Demange, University of Sao Paulo General Hospital
Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty - Randomized Prospective Study
The total knee arthroplasty (TKA) is a well established option for the treatment of osteoarthritis in this joint.
Nevertheless, there are still some concerns related to the peri-operative management of elderly patients, highlighting the complications related to medical comorbidity and bleeding produced by surgery.
One of the proposed methods to decrease postoperative bleeding, which has been accumulating favorable evidence, is the use of tranexamic acid (TA).
Several studies (including prospective randomized trials with placebo group) showed excellent results with TA intravenous administration during TKA, reducing the amount of bleeding, the drop in hemoglobin and the need for blood transfusion.
Another alternative to minimize bleeding is the use of topical hemostatic agent Floseal®, composed of thrombin and bovine gelatin.
This substance has presented significant benefits on bleeding control in several areas of medicine, including orthopedic surgery, but no action has yet been established in TKA.
The main objective is to evaluate the amount of bleeding, the drop in hemoglobin and the need for blood transfusion after TKA, comparing the use of TA, Floseal® and a control group.
The secondary objective is to evaluate the rate of adverse events in the studied groups.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo, Brazil, 05403-010
- Recruiting
- Hospital das Clínicas - University of São Paulo
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Contact:
- Tania Fernanda, B.A.
- Phone Number: +55 11 976515344
- Email: taniafernanda@terra.com.br
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Principal Investigator:
- Camilo P Helito, M.D.
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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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Indication for total knee arthroplasty
- 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:
- None
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
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Active Comparator: 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.
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Other Names:
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Active Comparator: Floseal®
Floseal® will be applied in regions of potential bleeding before the release of the pneumatic tourniquet.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Amount of bleeding
Time Frame: First two days post-operative
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Measure of the drain volume on the first two days post-operative
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First two days post-operative
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Drop in hemoglobin
Time Frame: Three days postoperative
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Difference between the preoperative hemoglobin and hemoglobin in the third postoperative
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Three days postoperative
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adverse events
Time Frame: 1 month
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1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Camilo P Helito, M.D., University of Sao Paulo
- Principal Investigator: Ricardo G Gobbi, M.D., University of Sao Paulo
- Principal Investigator: Luis Eduardo P Tirico, M.D., University of Sao Paulo
- Principal Investigator: Marco K Demange, Ph.D., University of Sao Paulo
- Study Director: Jose R Pecora, Ph.D., University of Sao Paulo
- Study Chair: Gilberto L Camanho, Ph.D., University of Sao Paulo
- Principal Investigator: Marcelo B Bonadio, M.D., University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
February 1, 2014
Primary Completion (Anticipated)
February 1, 2015
Study Completion (Anticipated)
May 1, 2015
Study Registration Dates
First Submitted
May 29, 2014
First Submitted That Met QC Criteria
May 30, 2014
First Posted (Estimate)
June 2, 2014
Study Record Updates
Last Update Posted (Estimate)
June 2, 2014
Last Update Submitted That Met QC Criteria
May 30, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/11297
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.