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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Tranexamic acid
Floseal®
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital das Clinicas - University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Tranexamic acid

Floseal®

Control group

Arm Description

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.

Floseal® will be applied in regions of potential bleeding before the release of the pneumatic tourniquet.

Outcomes

Primary Outcome Measures

Amount of bleeding
Measure of the drain volume on the first two days post-operative
Drop in hemoglobin
Difference between the preoperative hemoglobin and hemoglobin in the third postoperative

Secondary Outcome Measures

Adverse events

Full Information

First Posted
May 29, 2014
Last Updated
May 30, 2014
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02152917
Brief Title
Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty
Official Title
Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty - Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Floseal®
Arm Type
Active Comparator
Arm Description
Floseal® will be applied in regions of potential bleeding before the release of the pneumatic tourniquet.
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
TA
Intervention Type
Drug
Intervention Name(s)
Floseal®
Primary Outcome Measure Information:
Title
Amount of bleeding
Description
Measure of the drain volume on the first two days post-operative
Time Frame
First two days post-operative
Title
Drop in hemoglobin
Description
Difference between the preoperative hemoglobin and hemoglobin in the third postoperative
Time Frame
Three days postoperative
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tania Fernanda, B.A.
Phone
+55 11 976515344
Email
taniafernanda@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilo P Helito, M.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ricardo G Gobbi, M.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis Eduardo P Tirico, M.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marco K Demange, Ph.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose R Pecora, Ph.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gilberto L Camanho, Ph.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marcelo B Bonadio, M.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas - University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania Fernanda, B.A.
Phone
+55 11 976515344
Email
taniafernanda@terra.com.br
First Name & Middle Initial & Last Name & Degree
Camilo P Helito, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
31778430
Citation
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.
Results Reference
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Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty

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