Clinical trial NCT02152917: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Osteoarthritis
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Amount of bleeding
timeFrame: First two days post-operative
measure: Drop in hemoglobin
timeFrame: Three days postoperative
Secondary outcomes:
measure: Adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Camilo P Helito, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Ricardo G Gobbi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Luis Eduardo P Tirico, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Marco K Demange, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Jose R Pecora, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Gilberto L Camanho, Ph.D.
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Marcelo B Bonadio, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.