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This study compares the effect of three different dose levels of tranexamic acid(TXA)in reducing blood loss and transfusion requirements in cardiac valve surgery.
The effect of TXA to reduce perioperative blood loss and blood transfusion has been well established in many trials, but the optimal dosage of TXA in cardiac surgery has always been a problem of debate. This is a single-center randomized controlled trial to study different dose regimens of TXA in cardiac surgery. We use three different dose levels of TXA in cardiac valve surgery with CPB, and see if there are any differences in perioperative blood loss and transfusion requirements. Serious adverse events and seizure attacks are also recorded until three months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose group, | Experimental | A bolus of 10 mg/kg Tranexamic Acid followed by a maintenance dose of 10 mg/kg/h Tranexamic Acid until the end of surgery |
|
| middle-dose group, | Experimental | A bolus of 20 mg/kg Tranexamic Acid followed by a maintenance dose of 15 mg/kg/h Tranexamic Acid until the end of surgery |
|
| high-dose group | Experimental | A bolus of 30 mg/kg Tranexamic Acid followed by a maintenance dose of 20 mg/kg/h Tranexamic Acid until the end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| total postoperative drainage | The total chest tube drainage postoperatively | from the operation day to the discharge,an average of 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Red blood cells transfusion rate(%),Red blood cells transfusion volume(ml) | intraoperative and postoperative RBC transfusion rate and transfusion volume(for all patients and for transfused patients) | from the operation day to the discharge,an average of 7 days |
| Fresh frozen plasma transfusion rate(%),Fresh frozen plasma transfusion volume(ml) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases | Beijing | Beijing Municipality | 100037 | China |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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|
intraoperative and postoperative FFP transfusion rate and transfusion volume(for all patients and for transfused patients) |
| from the operation day to the discharge,an average of 7 days |
| Platelet transfusion rate(%),Platelet transfusion volume(ml) | intraoperative and postoperative platelet transfusion rate and transfusion volume(for all patients and for transfused patients) | from the operation day to the discharge,an average of 7 days |
| repeat surgery because of bleeding | rate of repeat surgery due to massive bleeding | from the operation day to the discharge,an average of 7 days |
| rate of death | rate of death | from the operation day to three months after surgery |
| seizure attack | any seizure attack is recorded | from the operation day to three months after surgery |
| length of stay in ICU and hospital | the length of stay in ICU and hospital | from the operation day to the discharge,an average of 7 days |