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Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric cardiac surgery with well balanced patients population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Active Comparator | 50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit. |
|
| Placebo | Placebo Comparator | same volume of normal saline was given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit in TXA group. same volume of normal saline was given in Placebo group. |
| Measure | Description | Time Frame |
|---|---|---|
| the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| blood loss 6 hours after surgery | 6 hours after surgery | |
| the amount of blood transfusion | 24 hour after surgery | |
| additional TXA administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuichiro Toda, MD, PhD | Department of Anesthesiology and Intensive Care, Okayama University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21947753 | Derived | Shimizu K, Toda Y, Iwasaki T, Takeuchi M, Morimatsu H, Egi M, Suemori T, Suzuki S, Morita K, Sano S. Effect of tranexamic acid on blood loss in pediatric cardiac surgery: a randomized trial. J Anesth. 2011 Dec;25(6):823-30. doi: 10.1007/s00540-011-1235-z. Epub 2011 Sep 24. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D014191 | Tranylcypromine |
| D000933 | Antifibrinolytic Agents |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 24 hours after surgery |
| chest closure time (protamine to skin closure) | at the end of surgery |
| re-exploration of chest for excess bleeding | within 24 hours after surgery |
| duration of mechanical ventilation | at the time of extubation |
| length of stay in intensive care unit | at the time of discharge from ICU |
| episode of thrombotic complication | from drug administration to hospital discharge |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011437 |
| Propylamines |
| D000588 | Amines |
| D050299 | Fibrin Modulating Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D006490 | Hemostatics |
| D003029 | Coagulants |
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |