Ondansetron and Blood Coagulation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Coagulation Disorder
• Intervention / Treatment: Drug: 0 ul of ondansetron; Drug: 0.2 ul of ondansetron; Drug: 2 ul of ondansetron; Drug: 20 ul of ondansetron

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National Univ. Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

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 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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Anticipated): November 15, 2023
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: B-2008/631-305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No