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A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty.
A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 1 months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receving TXA, Study group | Experimental | Tranexamic acid, Study group tranexamic acid 1g, intravenous injection, pre-operationally |
|
| Normal saline, Control group | Placebo Comparator | Not receiving tranexamic acid, Control group Normal saline 100mL, intravenous injection, pre-operationally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Allogeneic Blood Transfusion as a Measure of Efficacy | one week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Total Blood Loss as a Measure of Efficacy | one week after surgery | |
| Rate of Thrombotic Complications as a Measure of Safety | 1 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinyu Zhu, M.D. | Department of Orthropaedics, Xijing Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing hospital | Xi'an | Shaanxi | 710032 | 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 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Normal saline | Drug | 100 mL of normal saline intravenously approximately 15 minutes before incision |
|
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |