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Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02152917
Recruitment Status : Unknown
Verified May 2014 by Marco Kawamura Demange, University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
Marco Kawamura Demange, University of Sao Paulo General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Tranexamic acid Drug: Floseal® Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty - Randomized Prospective Study
Study Start Date : February 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Tranexamic acid
Other Name: TA

Active Comparator: Floseal®
Floseal® will be applied in regions of potential bleeding before the release of the pneumatic tourniquet.
Drug: Floseal®
No Intervention: Control group



Primary Outcome Measures :
  1. Amount of bleeding [ Time Frame: First two days post-operative ]
    Measure of the drain volume on the first two days post-operative

  2. Drop in hemoglobin [ Time Frame: Three days postoperative ]
    Difference between the preoperative hemoglobin and hemoglobin in the third postoperative


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 1 month ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152917


Contacts
Contact: Tania Fernanda, B.A. +55 11 976515344 taniafernanda@terra.com.br

Locations
Brazil
Hospital das Clinicas - University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05403-010
Contact: Tania Fernanda, B.A.    +55 11 976515344    taniafernanda@terra.com.br   
Principal Investigator: Camilo P Helito, M.D.         
Sponsors and Collaborators
University of Sao Paulo General Hospital
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

Responsible Party: Marco Kawamura Demange, Assistant Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02152917     History of Changes
Other Study ID Numbers: 2014/11297
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants