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To compare the efficacy and safety of topical tranexamic acid versus placebo in patients diagnosed with severe knee osteoarthritis who will undergo prosthetic knee surgery in terms of saving blood loss (estimated blood loss, decreased hemoglobin and Decrease in hematocrit).
Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin. Tranexamic acid binds to plasminogen when it is transformed into plasmin. The activity of the tranexamic acid-plasmin complex on fibrin activity is less than the activity of free plasmin alone.
There are two methods of presentation: one, as an injectable solution; Two as a clear, colorless aqueous solution.
Tranexamic acid in Spain is approved for use in the prevention and treatment of bleeding due to general fibrinolysis. As for its specific indications the investigators find that it is used for the treatment of metrorrhagia, menorrhagia, gastrointestinal hemorrhage, urinary hemorrhagic disorders after prostate surgery, surgery of ears, nose, throat, gynecological, thoracic, abdominal or cardiovascular or to counter associated hemorrhages To the administration of a fibrinolytic drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amchafibrin | Experimental | Estimated total blood loss, measured using the formula described by Nadler. A difference in estimated blood loss greater than or equal to 245 ml will be considered clinically relevant. |
|
| Saline Solution 0,9%. | Placebo Comparator | Comparator of tranexamic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amchafibrin | Drug | Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Saving blood loss in knee surgery | Total blood loss greater than 245 ml | 24 hours post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Time post-intervention of functional recovery in study subjects | Four weeks post-discharger | |
| Length of hospital stay in study subjects | Four weeks post-discharger |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta del Mar | Cadiz | 11009 | Spain |
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| Saline Solution | Other | Placebo |
|
|
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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