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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 FlosealĀ®, 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, FlosealĀ® and a control group. The secondary objective is to evaluate the rate of adverse events in the studied groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Active Comparator | 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. |
|
| FlosealĀ® | Active Comparator | FlosealĀ® will be applied in regions of potential bleeding before the release of the pneumatic tourniquet. |
|
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug |
|
| |
| FlosealĀ® |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of bleeding | Measure of the drain volume on the first two days post-operative | First two days post-operative |
| Drop in hemoglobin | Difference between the preoperative hemoglobin and hemoglobin in the third postoperative | Three days postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tania Fernanda, B.A. | Contact | +55 11 976515344 | taniafernanda@terra.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Camilo P Helito, M.D. | University of Sao Paulo | Principal Investigator |
| Ricardo G Gobbi, M.D. | University of Sao Paulo | Principal Investigator |
| Luis Eduardo P Tirico, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas - University of Sao Paulo | Recruiting | SĆ£o Paulo | SĆ£o Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31778430 | Derived | 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. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| C411004 | FloSeal Matrix |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
|
| University of Sao Paulo |
| Principal Investigator |
| Marco K Demange, Ph.D. | University of Sao Paulo | Principal Investigator |
| Jose R Pecora, Ph.D. | University of Sao Paulo | Study Director |
| Gilberto L Camanho, Ph.D. | University of Sao Paulo | Study Chair |
| Marcelo B Bonadio, M.D. | University of Sao Paulo | Principal Investigator |
| D012216 |
| Rheumatic Diseases |