Irrigating Fluid and Blood Coagulation

Study Overview
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Brief Summary
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Irrigating fluid absorbed during the endoscopic surgery may alter whole blood coagulation. However, little is known about the dose-response relationships of hemodilution. The investigators have therefore performed the present study to measure the effect of a mixture of 2.7% sorbitol-0.54% mannitol 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 Mixture of 2.7% Sorbitol-0.54% Mannitol Solution on Blood Coagulation: In-vitro, Observational Healthy-volunteer Study Using Rotational Thromboelastometry (ROTEM®)

Conditions
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Blood Coagulation Disorder

Intervention / Treatment
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* Other: A mixture of 2.7% sorbitol-0.54% mannitol solution


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 mixture of 2.7% sorbitol-0.54% mannitol solution | |
| 10% dilution<br>Blood specimen which was diluted with 10% level using a mixture of 2.7% sorbitol-0.54% mannitol solution | Other: A mixture of 2.7% sorbitol-0.54% mannitol solution<br>* Venous blood was taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 10%, 20%, and 40%) using a mixture of 2.7% sorbitol-0.54% mannitol solution.<br>|
| 20% dilution<br>Blood specimen which was diluted with 20% level using a mixture of 2.7% sorbitol-0.54% mannitol solution | Other: A mixture of 2.7% sorbitol-0.54% mannitol solution<br>* Venous blood was taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 10%, 20%, and 40%) using a mixture of 2.7% sorbitol-0.54% mannitol solution.<br>|
| 40% dilution<br>Blood specimen which was diluted with 40% level using a mixture of 2.7% sorbitol-0.54% mannitol solution | Other: A mixture of 2.7% sorbitol-0.54% mannitol solution<br>* Venous blood was taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 10%, 20%, and 40%) using a mixture of 2.7% sorbitol-0.54% mannitol 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 s a proper noun which means the status of fibrinolytic coagulation pathway. | 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 a proper noun which means the status of intrinsic coagulation pathway. | during the rotational thromboelastometry analysis/ an average of 1 hour | 
| EXTEM | Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is a proper noun which means the status of extrinsic coagulation pathway. | during the rotational thromboelastometry analysis/ an average of 1 hour |