Plasmalyte-148 Solution and Blood Coagulation

Study Overview
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Brief Summary
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Fluids administered intravenously may alter whole blood coagulation. However, little is known about the dose-response relationships of hemodilution in plasmalyte-148 solution. Investigators have therefore performed the present study to measure the effect of a plasmalyte-148 solution on the coagulation pathway according to the hemodilution level using a rotational thromboelastometry (ROTEM®) tests.

Official Title
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The Effect of a Plasmalyte-148 Solution on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry

Conditions
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Blood Coagulation Disorder

Intervention / Treatment
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* Other: Plasmalyte-148


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Age: 20 to 65 years Body weight > 50 kg Volunteers who provided informed consent Exclusion Criteria: Hematologic disease Anticoagulant medication

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 0% dilution<br>Blood specimen which was diluted with 0% level using a plasmalyte-148 solution | |
| 20% dilution<br>Blood specimen which was diluted with 20% level using a plasmalyte-148 solution | Other: Plasmalyte-148<br>* Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 20%, 40%, and 60%) using a plasmalyte-148 solution.<br>|
| 40% dilution<br>Blood specimen which was diluted with 40% level using a plasmalyte-148 solution | Other: Plasmalyte-148<br>* Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 20%, 40%, and 60%) using a plasmalyte-148 solution.<br>|
| 60% dilution<br>Blood specimen which was diluted with 60% level using a plasmalyte-148 solution | Other: Plasmalyte-148<br>* Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 20%, 40%, and 60%) using a plasmalyte-148 solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIBTEM | Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym. | During the rotational thromboelastometry analysis/ an average of 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INTEM | Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is not an acronym. | During the rotational thromboelastometry analysis/ an average of 1 hour | 
| EMTEM | Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is not an acronym. | During the rotational thromboelastometry analysis/ an average of 1 hour |