Palonosetron and Blood Coagulation

Study Overview
=================
Brief Summary
-----------------
Palonosetron may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of palonosetron. The investigators therefore will perform the present study to measure the effect of palonosetron levels using thromboelastography.

Official Title
-----------------
The Effect of a Palonosetron on Blood Coagulation: In Vitro, Volunteer Study Using Thromboelastography

Conditions
-----------------
Blood Coagulation Disorder

Intervention / Treatment
-----------------
* Drug: 0 ul of palonosetron
* Drug: 1 ul of palonosetron
* Drug: 10 ul of palonosetron
* Drug: 100 ul of palonosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
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 of 0 ul of palonosetron | Drug: 0 ul of palonosetron<br>* Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using palonosetron<br>|
| Experimental: 25 ng/ml<br>Blood specimen which was added of 1 ul of palonosetron | Drug: 1 ul of palonosetron<br>* Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (1 ul) using palonosetron<br>|
| Experimental: 250 ng/ml<br>Blood specimen which was added of 10 ul of palonosetron | Drug: 10 ul of palonosetron<br>* Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (10 ul) using palonosetron<br>|
| Experimental: 2500 ng/ml<br>Blood specimen which was added of 100 ul of palonosetron | Drug: 100 ul of palonosetron<br>* Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (100 ul) using palonosetron<br>|

What is the study measuring?
-----------------
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 Kaloin Heprinase | To measure the platelet function | During the thromboelastography analysis/ an average of 1 hour | 
| Activator F | To elimitate the platelt function | During the thromboelastography analysis/ an average of 1 hour | 
| Adenosine diphosphate | To measure the drug effect | During the thromboelastography analysis/ an average of 1 hour | 
| Arachidonic acid | To measure the drug effect | During the thromboelastography analysis/ an average of 1 hour |