Ondansetron and Blood Coagulation

NCT ID: NCT04499274

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2023-12-15

Brief Summary

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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

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Conditions

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Blood Coagulation Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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0 ng/ml

Blood specimen which was added 0 ul of ondansetron

Group Type EXPERIMENTAL

0 ul of ondansetron

Intervention Type DRUG

Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 nl) using ondansetron

200 ng/ml

Blood specimen which was added 0.20 ul of ondansetron

Group Type EXPERIMENTAL

0.2 ul of ondansetron

Intervention Type DRUG

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

2000 ng/ml

Blood specimen which was added 2 ul of ondansetron

Group Type EXPERIMENTAL

2 ul of ondansetron

Intervention Type DRUG

Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (2 ul) using ondansetron

20000 ng/ml

Blood specimen which was added 20 ul of ondansetron

Group Type EXPERIMENTAL

20 ul of ondansetron

Intervention Type DRUG

Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (20 ul) using ondansetron

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Hematologic disease
* Anticoagulant medication
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyo-Seok Na, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyo-Seok Na, MD., PhD.

Role: CONTACT

82317877507

Facility Contacts

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Hyo-Seok Na

Role: primary

1087012913

Other Identifiers

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B-2008/631-305

Identifier Type: -

Identifier Source: org_study_id

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