Ondansetron and Blood Coagulation

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04499274
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 26.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Coagulation Disorder	Drug: 0 ul of ondansetron; Drug: 0.2 ul of ondansetron; Drug: 2 ul of ondansetron; Drug: 20 ul of ondansetron	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Effect of an Ondansetron on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry
• Actual Study Start Date: Sep 16, 2020
• Anticipated Primary Completion Date: Nov 15, 2022
• Anticipated Study Completion Date: Dec 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Citrated Functional Fibrinogen [During the thromboelastography analysis/ an average of 1 hour]

   Provides clot strength based on fibrinogen contribution

Secondary Outcome Measures

1. Citrated Kaolin [During the thromboelastography analysis/ an average of 1 hour]

   Normal thromboelastography

2. Citrated Kaolin Heparinase [During the thromboelastography analysis/ an average of 1 hour]

   To assess the effect of heparin

3. Citrated Rapid Thromboelastography [During the thromboelastography analysis/ an average of 1 hour]

   A quicker assessment of clot strength, without assessment of clot initiation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy vonlunteers

• Age: 20 to 65 years

• Body weight > 50 kg

• Volunteers who provided informed consent

Exclusion Criteria:

• Hematologic disease

• Anticoagulant medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National Univ. Bundang Hospital	Seongnam	Gyeonggi	Korea, Republic of	463-707

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

• Principal Investigator: Hyo-Seok Na, MD., PhD., Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyo-Seok Na, Professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT04499274
• Other Study ID Numbers: B-2008/631-305
• First Posted: Aug 5, 2020
• Last Update Posted: Apr 7, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Ondansetron

Study Results

No Results Posted as of Apr 7, 2022