The Effects of Low-dose Epinephrine Plus Tranexamic Acid on Perioperative Haemostasis and Inflammatory Reaction in Major Surgery

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 hip 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 as having osteoarthritis or osteonecrosis of the femoral head Scheduled for an elective primary total hip arthroplasty 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: 18 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 |
| --- | --- | --- |
| Blood loss on post-operative day 1 |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | 1 months | 
| Number of patients with infection |  | 1 months | 
| Number of deep vein thrombosis cases |  | 1 months | 
| Number of pulmonary embolism cases |  | 1 months | 
| Number of plexus venosus leg muscle thrombosis |  | 1 months | 
| Serum levels of IL-10（Preoperation, intraoperation and post-operation） |  | Preoperation, intraoperation and up to 2 days post-operation | 
| Serum levels of IL-6（Preoperation, intraoperation and post-operation） |  | Preoperation, intraoperation and up to 2 days post-operation | 
| Serum levels of IL-1β（Preoperation, intraoperation and post-operation） |  | Preoperation, intraoperation and up to 2 days post-operation | 
| Serum levels of TNF-α（Preoperation, intraoperation and post-operation） |  | Preoperation, intraoperation and up to 2 days post-operation | 
| Haemoglobin (Hb) |  | 7 days | 
| Hematocrit (Hct) |  | 7 days | 
| Platelets (PLT) |  | 7 days | 
| Blood loss on post-operative day 3 |  | 3 days | 
| Preoperation, intraoperation and post-operation R value (min) of thrombelastogram |  | Preoperation, intraoperation and up to 2 days post-operation | 
| Preoperation, intraoperation and post-operation K value (min) of thrombelastogram |  | Preoperation, intraoperation and up to 2 days post-operation | 
| Preoperation, intraoperation and post-operation Angle (deg) of thrombelastogram |  | Preoperation, intraoperation and up to 2 days post-operation | 
| Preoperation, intraoperation and post-operation MA (mm) of thrombelastogram |  | Preoperation, intraoperation and up to 2 days post-operation | 
| Preoperation, intraoperation and post-operation comprehensive index of blood clotting (CI) of thrombelastogram |  | Preoperation, intraoperation and up to 2 days post-operation | 
| Preoperation, intraoperation and post-operation LY30 (%) of thrombelastogram |  | Preoperation, intraoperation and up to 2 days post-operation | 
| Number of patients with blood transfusion | Number of transfusion cases, number of units transfused and amount of transfusion | 7 days | 

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