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Hip fracture in elderly patients is a pathology with a high economic and health impact on the patient himself and on the National Health System, especially considering the significant aging of the population of the Basque Country. Despite advances, hip fracture remains in the clinical groups with the highest in-hospital mortality. Hip fracture is associated with numerous adverse events and high mortality.
Numerous antifibrinolytics, such as tranexamic acid (TXA), have been used to limit bleeding in orthopedic surgery and thus prevent the need for blood transfusion. Numerous studies have shown that the use of tranexamic acid does not increase the risk of thrombosis.
It is proposed to carry out clinical research with drugs without commercial interest. A randomized, double-blind clinical trial to assess the efficacy of tranexamic acid in reducing blood loss in elderly patients with hip fracture.
Prevention and treatment of bleeding due to general or local fibrinolysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracapsular fracture with intravenous contraindication (control). | Placebo Comparator | Physiological saline |
|
| Extracapsular fracture with intravenous contraindication (experimental). | Experimental | Amchafibrin |
|
| Extracapsular fracture without intravenous contraindication (control). | Placebo Comparator | Physiological saline |
|
| Extracapsular fracture without intravenous contraindication (experimental). | Experimental | Amchafibrin |
|
| Intracapsular fracture with intravenous contraindication (control). | Placebo Comparator | Physiological saline |
|
| Intracapsular fracture with intravenous contraindication (experimental). | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Intravenous or topical administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood transfusion | Transfusion rate from patient admission to hospital discharge. | From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation. |
| Measure | Description | Time Frame |
|---|---|---|
| Total blood loss | From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation. | |
| Adverse events | 3,6,9 and 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Instituto Biodonostia | San Sebastián | Guipuzcoa | 20014 | Spain |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip 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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Amchafibrin
|
| Intracapsular fracture without intravenous contraindication (control). | Active Comparator | Physiological saline |
|
| Intracapsular fracture without intravenous contraindication (experimental). | Experimental | Amchafibrin |
|
| Physiologic saline | Other | Placebo |
|
| Days at hospital |
| From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation. |
| D007869 |
| Leg Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |