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The purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | A 500 mg loading dose of tranexamic acid diluted in 100 ml of saline solution will be slowly administered intravenously to patients 20 minutes before surgery, followed by a continuos infusion of 250 mg/h of tranexamic acid from surgical incision until skin closure. |
|
| Placebo | Placebo Comparator | Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tranexamic acid diluted in 100 ml of saline solution (loading dose) | Drug |
| ||
| tranexamic acid undiluted (continous infusion) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss (milliliters) | intraoperative (from skin incision to skin closure) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of packed blood red cells transfused | hospital stay (an average of one week) | |
| Occurrence of thromboembolic events (of any nature) | 28-days and one year after surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Scientific Institute | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31607387 | Derived | Monaco F, Nardelli P, Pasin L, Barucco G, Mattioli C, Di Tomasso N, Dalessandro G, Giardina G, Landoni G, Chiesa R, Zangrillo A. Tranexamic acid in open aortic aneurysm surgery: a randomised clinical trial. Br J Anaesth. 2020 Jan;124(1):35-43. doi: 10.1016/j.bja.2019.08.028. Epub 2019 Oct 10. |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Drug |
|
| Placebo | Drug | Saline |
|
| Mortality |
| 28-days and one year after surgery |