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

Phase 4

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Tranexamic acid; Drug: Floseal®

• Registration Number: NCT02152917
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Status Verified: 2014-05
• Study First Submitted: 2014-05-29
• Study First Submitted QC: 2014-05-30
• Last Update Submitted: 2014-05-30
• Study First Posted: 2014-06-02
• Last Update Posted: 2014-06-02
• Primary Completion: 2015-02
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	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.
Floseal®	Floseal®	Floseal® will be applied in regions of potential bleeding before the release of the pneumatic tourniquet.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse events	1 month

Trial Locations

Locations (1)

Hospital das Clinicas - University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil