Ondansetron and Blood Coagulation

Not Applicable

Recruiting

• Conditions: Blood Coagulation Disorder
• Interventions: Drug: 0 ul of ondansetron; Drug: 0.2 ul of ondansetron; Drug: 2 ul of ondansetron; Drug: 20 ul of ondansetron

• Registration Number: NCT04499274
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-05
• Study Start: 2020-09-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15
• Primary Completion: 2023-11-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy vonlunteers
• Age: 20 to 65 years
• Body weight > 50 kg
• Volunteers who provided informed consent

Exclusion Criteria

• Hematologic disease
• Anticoagulant medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0 ng/ml	0 ul of ondansetron	Blood specimen which was added 0 ul of ondansetron
200 ng/ml	0.2 ul of ondansetron	Blood specimen which was added 0.20 ul of ondansetron
2000 ng/ml	2 ul of ondansetron	Blood specimen which was added 2 ul of ondansetron
20000 ng/ml	20 ul of ondansetron	Blood specimen which was added 20 ul of ondansetron

Primary Outcome Measures

Name	Time	Method
Citrated Functional Fibrinogen	During the thromboelastography analysis/ an average of 1 hour	Provides clot strength based on fibrinogen contribution

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National Univ. Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of