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| Name | Class |
|---|---|
| Tel-Aviv Sourasky Medical Center | OTHER_GOV |
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This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Patients will receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours. |
|
| GROUP B | Experimental | Patients will receive IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours. |
|
| GROUP C | Placebo Comparator | A control group will only receive placebo in the emergency room and in the OR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | GROUP A - receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours. GROUP B - IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours. Group C - A control group will only receive placebo in the emergency room and in the OR. |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of blood loss per patient from admission to day 5 post-op | 5 DAYS |
| Measure | Description | Time Frame |
|---|---|---|
| Number of packed cell transfusion per patient. | 5 DAYS | |
| Initial functional outcome and feeling of well-being. | 5 days | |
| thromboembolic events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ELI SHTEINBERG, MD | Tel-Aviv Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sourasky Medical Center | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 5 days |
| post-operative bacterial infection | 5 days |
| 30 day mortality rate | 30 days |