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The aim of this study is to investigate the hypothesis that single dose of tranexamic acid (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing and cemented hemiarthroplasty respectively. After application of inclusion and exclusion criteria, patients will be randomized in two groups. Group 1 will include patients that receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that receive normal saline (control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | intravenous tranexamic acid, 15mg/kg, preoperatively, single dose |
|
| Group 2 | Placebo Comparator | Intravenous normal saline, 100mg, preoperatively, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid 15mg/kg , iv, Single Dose | Drug | Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of transfusions of allogeneic RBC from surgery up to day 4 | 5 days | |
| total blood loss from surgery to day | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of vascular events | 3 months | |
| Incidence of deaths | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vasileios S Nikolaou, MD | Contact | +306932543400 | vassilios.nikolaou@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Department of Orthopaedics | Recruiting | Athens | Attica | 14233 | Greece |
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| Normal Saline, 100mg, iv, Singe dose | Drug | Normal Saline, 100mg, administered intravenously, preoperatively in single dose |
|
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D006620 | Hip Fractures |
| D011183 | Postoperative Complications |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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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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