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Ondansetron and Blood Coagulation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04499274
Enrollment
12
Registered
2020-08-05
Start date
2020-09-16
Completion date
2023-12-15
Last updated
2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Coagulation Disorder

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.

Interventions

DRUG0 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

DRUG0.2 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

DRUG2 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

DRUG20 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

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Citrated Functional FibrinogenDuring the thromboelastography analysis/ an average of 1 hourProvides clot strength based on fibrinogen contribution

Secondary

MeasureTime frameDescription
Citrated Kaolin HeparinaseDuring the thromboelastography analysis/ an average of 1 hourTo assess the effect of heparin
Citrated Rapid ThromboelastographyDuring the thromboelastography analysis/ an average of 1 hourA quicker assessment of clot strength, without assessment of clot initiation
Heparinized Kaolin HeparinaseDuring the thromboelastography analysis/ an average of 1 hourTo measure the platelet function
Citrated KaolinDuring the thromboelastography analysis/ an average of 1 hourNormal thromboelastography
Adenosine diphosphateDuring the thromboelastography analysis/ an average of 1 hourTo masure the drug effect
Arachidonic acidDuring the thromboelastography analysis/ an average of 1 hourTo masure the drug effect
Activator FDuring the thromboelastography analysis/ an average of 1 hourTo eliminate the platelet function

Countries

South Korea

Contacts

Primary ContactHyo-Seok Na, MD., PhD.
hsknana@gmail.com82317877507

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026