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Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The current study includes patients receiving valvular replacement and coronary artery bypass surgery. Three dosage regimen of tranexamic acid is delivered and blood loss, transfusions and clinical outcomes are recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dosage | Experimental | Tranexamic acid with a loading dose of 30 mg/kg and a maintenance infusion of 20 mg/kg/h |
|
| Medium dosage | Experimental | Tranexamic acid with a loading dose of 20 mg/kg and a maintenance infusion of 15 mg/kg/h |
|
| Low dosage | Experimental | Tranexamic acid with a loading dose of 10 mg/kg and a maintenance infusion of 10 mg/kg/h |
|
| Control | Placebo Comparator | Saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug |
| ||
| Saline Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of exposure to allogeneic erythrocytes transfusions | Allogeneic RBCs were transfused if the hemoglobin level was less than 6 g/dL during cardiopulmonary bypass, less than 8 g/dL postoperatively, or less than 9 g/dL for elderly people (>70 years). | Perioperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of allogeneic erythrocytes transfusions | Allogeneic RBCs were transfused if the hemoglobin level was less than 6 g/dL during cardiopulmonary bypass, less than 8 g/dL postoperatively, or less than 9 g/dL for elderly people (>70 years). | Perioperatively |
| Rate and volume of fresh frozen plasma transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lihuan Li, MD | Contact | 86-10-88398184 | llhfw@sina.com | |
| Jia Shi, MD | Contact | 86-10-88322467 | shiandypumc@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Lihuan Li, MD | Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC | Study Chair |
| Jia Shi, MD | Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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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 |
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| Drug |
|
| Perioperatively |
| Rate and volume of allogeneic platelet transfusion | Perioperatively |
| Rate of reexploration for hemostasis | Perioperatively |
| Postoperative blood loss | Defined as total volume of chest drainage postoperatively | Postoperatively |
| Thromboelastography | Perioperatively |
| Coagulatory and fibrinolytic associated moleculars | FIB, FDP, FXI:C, AT-III, D-dimer and TXB2 | Perioperatively |
| Inflammation associated moleculars | ET-1, IL-2, IL-6, IL-8, IL-10, TNF-α, NE, FN and PGI2 | Perioperatively |
| Length of stay in ICU and hospital postoperatively | Postoperatively |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |