Ondansetron and Blood Coagulation

Study Overview
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Brief Summary
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Ondansetron may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of ondansetron. The investigators therefore will perform the present study to measure the effect of ondansestron on the blood coagulation pathway according to the drug concentration level using a thromboelastography test.

Official Title
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The Effect of an Ondansetron on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry

Conditions
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Blood Coagulation Disorder

Intervention / Treatment
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* Drug: 0 ul of ondansetron
* Drug: 0.2 ul of ondansetron
* Drug: 2 ul of ondansetron
* Drug: 20 ul of ondansetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy vonlunteers 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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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0 ng/ml<br>Blood specimen which was added 0 ul of ondansetron | Drug: 0 ul of ondansetron<br>* Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 nl) using ondansetron<br>|
| Experimental: 200 ng/ml<br>Blood specimen which was added 0.20 ul of ondansetron | Drug: 0.2 ul of ondansetron<br>* Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.2 ul) using ondansetron<br>|
| Experimental: 2000 ng/ml<br>Blood specimen which was added 2 ul of ondansetron | Drug: 2 ul of ondansetron<br>* Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (2 ul) using ondansetron<br>|
| Experimental: 20000 ng/ml<br>Blood specimen which was added 20 ul of ondansetron | Drug: 20 ul of ondansetron<br>* Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (20 ul) using ondansetron<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Citrated Functional Fibrinogen | Provides clot strength based on fibrinogen contribution | During the thromboelastography analysis/ an average of 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Citrated Kaolin | Normal thromboelastography | During the thromboelastography analysis/ an average of 1 hour | 
| Citrated Kaolin Heparinase | To assess the effect of heparin | During the thromboelastography analysis/ an average of 1 hour | 
| Citrated Rapid Thromboelastography | A quicker assessment of clot strength, without assessment of clot initiation | During the thromboelastography analysis/ an average of 1 hour | 
| Heparinized Kaolin Heparinase | To measure the platelet function | During the thromboelastography analysis/ an average of 1 hour | 
| Activator F | To eliminate the platelet function | During the thromboelastography analysis/ an average of 1 hour | 
| Adenosine diphosphate | To masure the drug effect | During the thromboelastography analysis/ an average of 1 hour | 
| Arachidonic acid | To masure the drug effect | During the thromboelastography analysis/ an average of 1 hour |