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

Knee Osteoarthritis Clinical Trial

Official title:

Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty - Randomized Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02152917
• Other study ID #: 2014/11297
• Status: Recruiting
• Phase: Phase 4
• First received: May 29, 2014
• Last updated: May 30, 2014
• Start date: February 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2014
• Source: University of Sao Paulo General Hospital
• Contact: Tania Fernanda, B.A.
• Phone: +55 11 976515344
• Email: taniafernanda[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Tranexamic acid

• Floseal®

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas - University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of bleeding	Measure of the drain volume on the first two days post-operative	First two days post-operative	No
Primary	Drop in hemoglobin	Difference between the preoperative hemoglobin and hemoglobin in the third postoperative	Three days postoperative	No
Secondary	Adverse events		1 month	No