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

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: Knee Osteoarthritis
• Intervention / Treatment: Drug: Tranexamic acid; Drug: Floseal®

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-010
    • Recruiting
    • Hospital das Clínicas - University of São Paulo
    • Contact: Tania Fernanda, B.A.; Phone Number: +55 11 976515344; Email: taniafernanda@terra.com.br
    • Principal Investigator: Camilo P Helito, M.D.

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
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 Names: TA
Active Comparator: Floseal®; Floseal® will be applied in regions of potential bleeding before the release of the pneumatic tourniquet.	Drug: Floseal®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of bleeding	Measure of the drain volume on the first two days post-operative	First two days post-operative
Drop in hemoglobin	Difference between the preoperative hemoglobin and hemoglobin in the third postoperative	Three days postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	1 month

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

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: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2014/11297