The Effect of Tranexamic Acid for Total Hip Arthroplasty

Study Overview
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Brief Summary
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The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.

Detailed Description
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Orthopedic surgery may be associated with substantial blood loss requiring transfusion of erythrocytes.Transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, and transfusion related acute lung injury. Measures taken to allay concerns about the safety of blood transfusions have translated into the increasing cost of allogeneic blood units. Blood banks regularly undergo blood shortages. For these reasons, there is a need to reduce allogeneic blood transfusions. A number of effective interventions have been developed, such as preoperative autologous donation, cell salvage, or the use of erythropoietin. Pharmacologic agents such as aprotinin, tranexamic acid, or epsilon-aminocaproic acid (EACA) could reduce perioperative blood loss by interfering with fibrinolysis.

Official Title
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The Effects of High Doze Tranexamic Acid Application on Hemorrhage, Blood Transfusion, Fibrin Degradation Products, and Kidney Functions for Total Hip Arthroplasty

Conditions
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Hemorrhage

Intervention / Treatment
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* Drug: tranexamic acid
* Drug: serum physiologic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 2-3 18-75 age total hip arthroplasty surgery regional anesthesia Exclusion Criteria: allergies to drug liver and kidney failure ischemic heart disease coagulopathy

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tranexamic acid<br>preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes | Drug: tranexamic acid<br>* preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes<br>* Other names: lysteda;|
| Sham Comparator: serum physiologic<br>preoperative 100 cc serum physiologic | Drug: serum physiologic<br>* preoperative 100 cc ıv serum physiologic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemorrhage | the amount of bleeding in aspirator and sponges | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erythrocyte transfusion |  | intraoperative and postoperative 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, total hip arthroplasty