search
Back to results

Ondansetron and Blood Coagulation

Primary Purpose

Blood Coagulation Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
0 ul of ondansetron
0.2 ul of ondansetron
2 ul of ondansetron
20 ul of ondansetron
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Blood Coagulation Disorder

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Hematologic disease
  • Anticoagulant medication

Sites / Locations

  • Seoul National Univ. Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

0 ng/ml

200 ng/ml

2000 ng/ml

20000 ng/ml

Arm Description

Blood specimen which was added 0 ul of ondansetron

Blood specimen which was added 0.20 ul of ondansetron

Blood specimen which was added 2 ul of ondansetron

Blood specimen which was added 20 ul of ondansetron

Outcomes

Primary Outcome Measures

Citrated Functional Fibrinogen
Provides clot strength based on fibrinogen contribution

Secondary Outcome Measures

Citrated Kaolin
Normal thromboelastography
Citrated Kaolin Heparinase
To assess the effect of heparin
Citrated Rapid Thromboelastography
A quicker assessment of clot strength, without assessment of clot initiation
Heparinized Kaolin Heparinase
To measure the platelet function
Activator F
To eliminate the platelet function
Adenosine diphosphate
To masure the drug effect
Arachidonic acid
To masure the drug effect

Full Information

First Posted
July 31, 2020
Last Updated
March 13, 2023
Sponsor
Seoul National University Bundang Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04499274
Brief Title
Ondansetron and Blood Coagulation
Official Title
The Effect of an Ondansetron on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Coagulation Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0 ng/ml
Arm Type
Experimental
Arm Description
Blood specimen which was added 0 ul of ondansetron
Arm Title
200 ng/ml
Arm Type
Experimental
Arm Description
Blood specimen which was added 0.20 ul of ondansetron
Arm Title
2000 ng/ml
Arm Type
Experimental
Arm Description
Blood specimen which was added 2 ul of ondansetron
Arm Title
20000 ng/ml
Arm Type
Experimental
Arm Description
Blood specimen which was added 20 ul of ondansetron
Intervention Type
Drug
Intervention Name(s)
0 ul of ondansetron
Intervention Description
Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 nl) using ondansetron
Intervention Type
Drug
Intervention Name(s)
0.2 ul of ondansetron
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
2 ul of ondansetron
Intervention Description
Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (2 ul) using ondansetron
Intervention Type
Drug
Intervention Name(s)
20 ul of ondansetron
Intervention Description
Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (20 ul) using ondansetron
Primary Outcome Measure Information:
Title
Citrated Functional Fibrinogen
Description
Provides clot strength based on fibrinogen contribution
Time Frame
During the thromboelastography analysis/ an average of 1 hour
Secondary Outcome Measure Information:
Title
Citrated Kaolin
Description
Normal thromboelastography
Time Frame
During the thromboelastography analysis/ an average of 1 hour
Title
Citrated Kaolin Heparinase
Description
To assess the effect of heparin
Time Frame
During the thromboelastography analysis/ an average of 1 hour
Title
Citrated Rapid Thromboelastography
Description
A quicker assessment of clot strength, without assessment of clot initiation
Time Frame
During the thromboelastography analysis/ an average of 1 hour
Title
Heparinized Kaolin Heparinase
Description
To measure the platelet function
Time Frame
During the thromboelastography analysis/ an average of 1 hour
Title
Activator F
Description
To eliminate the platelet function
Time Frame
During the thromboelastography analysis/ an average of 1 hour
Title
Adenosine diphosphate
Description
To masure the drug effect
Time Frame
During the thromboelastography analysis/ an average of 1 hour
Title
Arachidonic acid
Description
To masure the drug effect
Time Frame
During the thromboelastography analysis/ an average of 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy vonlunteers Age: 20 to 65 years Body weight > 50 kg Volunteers who provided informed consent Exclusion Criteria: Hematologic disease Anticoagulant medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyo-Seok Na, MD., PhD.
Phone
82317877507
Email
hsknana@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo-Seok Na, MD., PhD.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National Univ. Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo-Seok Na
Phone
1087012913
Email
hsknana@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Ondansetron and Blood Coagulation

We'll reach out to this number within 24 hrs