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

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: Tranexamic acid; Drug: Floseal®

Study type: Interventional

Funder types: Other

Identifiers

NCT02152917

2014/11297

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Tranexamic acid

Active Comparator group

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.

Treatment:

Drug: Tranexamic acid

Floseal®

Active Comparator group

Description:

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

Treatment:

Drug: Floseal®

Control group

No Intervention group