Rotational Thromboelastography Study in Tranexamic Acid and Colloid Infusion

Study Overview
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Brief Summary
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Colloid solution is generally used to maintain intravascular volume. It is reported to impair blood coagulation in vivo and in vitro more than crystalloid does by prolonging coagulation time and decreasing clot strength. The formed fibrin clot is more vulnerable for fibrinolysis in a case of using colloid. Dilution of plasmin in vitro with colloid enhances fibrinolysis primarily by diminishing α2-antiplasmin-plasmin interaction. Tranexamic acid is an antifibrinolytics that competitively inhibits the activation of plasminogen, by binding to specific site of both plasminogen and plasmin, a molecule responsible for the degradation of fibrin, a protein that forms the framework of blood clot. It is used to treat or prevent excessive blood loss during surgery and in other medical conditions. Gastrointestinal effect, dizziness, fatigue, headache, hypersensitivity reaction, or potential risk of thrombosis is reported as the adverse effect of tranexamic acid. We hypothesized that inhibition of plasmin by tranexamic acid after colloid administration can improve the colloid-induced clot strength impairment.

Official Title
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The Effect of Tranexamic Acid on Blood Coagulation After Colloid Infusion During Surgery: Rotational Thromboelastography Measurement

Conditions
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Avascular Necrosis of Femoral Head, Degenerative Arthritis of Hip

Intervention / Treatment
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* Drug: Tranexamic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing total hip replacement arthroplasty, who are diagnosed with the avascular necrosis of femoral head or degenerative arthritis of hip American Society of Anesthesiologist I or II Exclusion Criteria: Patients receiving an intraoperative transfusion Patients receiving thrombin Patients having venous thromboembolism Patients having renal or hepatic disease Patients having coagulopathy Patient having heart failure

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Colloid<br>During the operation, Lactate Ringer's solution is used as the maintenance fluid, and colloid is infused for the compensation of the intraoperative blood loss. | |
| Experimental: Tranexamic acid<br>During the operation, Lactate Ringer's solution is used as the maintenance fluid, and colloid is infused for the compensation of the intraoperative blood loss. In addition, 1 g of tranexamic acid in 100 ml normal saline is administered intravenously over 30 min after finishing the procedure of hip implant insertion. | Drug: Tranexamic Acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotational thromboelastography |  | 30 minutes before starting an operation and 30 minutes after finishing an operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin |  | 30 minutes before starting an operation and 30 minutes after finishing an operation | 
| Platelet |  | 30 minutes before starting an operation and 30 minutes after finishing an operation | 
| International normalized ratio of prothrombin time |  | 30 minutes before starting an operation and 30 minutes after finishing an operation | 
| Activated partial thromboplastin time |  | 30 minutes before starting an operation and 30 minutes after finishing an operation | 
| Fibrinogen |  | 30 minutes before starting an operation and 30 minutes after finishing an operation |