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The purpose of this study is to compare the blood loss of intravenous and topical administration of low dose epinephrine plus combined administration of intravenous and topical tranexamic acid for primary total knee arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous epinephrine | Experimental | Intravenous (IV) low dose epinephrine |
|
| Topical epinephrine | Experimental | Topical epinephrine |
|
| Control | Active Comparator | No epinephrine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid (TXA) | Drug | IV and topical administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total blood loss on the post-operative day 1 | 1 day post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin (Hb) | g/L | 7 day |
| Hematocrit (Hct) | Percentage | 7 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
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| Epinephrine | Drug |
|
| Blood platelet count (PLT) |
| 7 day |
| Post-operation Hospital for special surgery score (HSS) | Scoring | 3 months |
| Preoperative and post-operation range of motion (ROM) of operated knee joint (degree) | There is only one Unit of Measure for ROM, it is degree | Through study completion, an average of 3 months |
| Length of hospital stay (days) | Days | 3 months |
| Number of patients with infection | Post-operatively | 3 months |
| Number of deep vein thrombosis (DVT) cases | Post-operatively | 1 month |
| Number of pulmonary embolism (PE) cases | Post-operatively | 1 month |
| Intraoperative blood loss | Post-operatively | 3 hours |
| Intravenous fluid administration on the operation day | Milliliter | 1 day |
| Total blood loss on the post-operative day 3 | Milliliter | 3 day post-operation |
| Reaction time (R-time) | 24 hours |
| Rate of thrombus formation (K time) | 24 hours |
| Maximum amplitude (MA) | 24 hours |
| Rate of thrombus formation (α-angle) | 24 hours |
| Lysis rate at 30 min (LY30) | 24 hours |
| Coagulation index (CI) | 24 hours |
| Interleukin(IL)-1β | 24 hours |
| Interleukin(IL)-6 | 24 hours |
| Interleukin(IL)-8 | 24 hours |
| Tumor necrosis factor (TNF)-α | 24 hours |
| C-reactive protein (CRP) | 24 hours |
| Interleukin(IL)-10 | 24 hours |
| Wound score | 14 day |
| Blood transfusion rate | 7 day |
| Blood transfusion volume (mL) | 7 day |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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