Intravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Conditions
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Blood Loss

Intervention / Treatment
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* Drug: Tranexamic acid (TXA)
* Drug: Epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients between the ages of 20 and 75 who were diagnosed with osteoarthritis of the knee and scheduled for an elective primary total knee arthroplasty and those who were willing and able to return for follow-up over at least a 6-month postoperative period Exclusion Criteria: Acute coronary syndrome < 6 months Glaucoma,pheochromocytoma, thyrotoxicosis, digoxin intoxication, serum potassium < 3.0 mmol, alcohol abuse, premenopausal women Current treatment with adenosine diphosphate (ADP) receptor antagonists, Factor Xa or thrombin inhibitors,heparin (excluding Low Molecular Weight Heparin (LMWH) for perioperative thromboprophylaxis), tricyclic antidepressants, or monoamine oxidase（MAO) or Catechol-O-methyltransferase (COMT) inhibitors Patients with history of thromboembolic disease, bleeding disorder Patients with history of renal impairment, cardiovascular diseases (previous myocardial infarction, atrial fibrillation) or cerebrovascular conditions (previous stroke or peripheral vascular surgery) Allergy to TXA

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous epinephrine<br>Intravenous (IV) low dose epinephrine | Drug: Tranexamic acid (TXA)<br>* IV and topical administration<br>Drug: Epinephrine<br> <br> |
| Experimental: Topical epinephrine<br>Topical epinephrine | Drug: Tranexamic acid (TXA)<br>* IV and topical administration<br>Drug: Epinephrine<br> <br> |
| Active Comparator: Control<br>No epinephrine | Drug: Tranexamic acid (TXA)<br>* IV and topical administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood loss on the post-operative day 1 |  | 1 day post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin (Hb) | g/L | 7 day | 
| Hematocrit (Hct) | Percentage | 7 day | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Replacement, Knee, Epinephrine, Tranexamic acid