Skip to content

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02152917
Enrollment
45
Registered
2014-06-02
Start date
2014-02-28
Completion date
2015-05-31
Last updated
2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

DRUGTranexamic acid

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Amount of bleedingFirst two days post-operativeMeasure of the drain volume on the first two days post-operative
Drop in hemoglobinThree days postoperativeDifference between the preoperative hemoglobin and hemoglobin in the third postoperative

Secondary

MeasureTime frame
Adverse events1 month

Countries

Brazil

Contacts

Primary ContactTania Fernanda, B.A.
taniafernanda@terra.com.br+55 11 976515344

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026