CClinicalTrials.gg
Status unknownNCT04499274Updated Mar 15, 2023

Ondansetron and Blood Coagulation

An interventional study of 0 ul of ondansetron and 0.2 ul of ondansetron in Blood Coagulation Disorder, sponsored by Seoul National University Bundang Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Blood Coagulation Disorder
03

In context

Hemostatic Disorders

503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.

This study's planned enrollment of 12 is below the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

  • Hematologic disease
  • Anticoagulant medication
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    0 ng/ml

    Blood specimen which was added 0 ul of ondansetron

    Drug: 0 ul of ondansetron

  • Experimental
    200 ng/ml

    Blood specimen which was added 0.20 ul of ondansetron

    Drug: 0.2 ul of ondansetron

  • Experimental
    2000 ng/ml

    Blood specimen which was added 2 ul of ondansetron

    Drug: 2 ul of ondansetron

  • Experimental
    20000 ng/ml

    Blood specimen which was added 20 ul of ondansetron

    Drug: 20 ul of ondansetron

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

06

What researchers measure

Primary outcomes

  1. Citrated Functional Fibrinogen

    Provides clot strength based on fibrinogen contribution

    Time frame: During the thromboelastography analysis/ an average of 1 hour

Secondary outcomes

  1. Citrated Kaolin

    Normal thromboelastography

    Time frame: During the thromboelastography analysis/ an average of 1 hour

  2. Citrated Kaolin Heparinase

    To assess the effect of heparin

    Time frame: During the thromboelastography analysis/ an average of 1 hour

  3. Citrated Rapid Thromboelastography

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

    Time frame: During the thromboelastography analysis/ an average of 1 hour

  4. Heparinized Kaolin Heparinase

    To measure the platelet function

    Time frame: During the thromboelastography analysis/ an average of 1 hour

  5. Activator F

    To eliminate the platelet function

    Time frame: During the thromboelastography analysis/ an average of 1 hour

  6. Adenosine diphosphate

    To masure the drug effect

    Time frame: During the thromboelastography analysis/ an average of 1 hour

  7. Arachidonic acid

    To masure the drug effect

    Time frame: During the thromboelastography analysis/ an average of 1 hour

07

Study locations

1 of 1 sites recruiting
  • Seoul National Univ. Bundang Hospital
    Seongnam, Gyeonggi 463-707, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04499274
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Hyo-Seok Na (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Aug 5, 2020
Start date
Sep 16, 2020
Primary completion
Nov 15, 2023 (estimated)
Completion
Dec 15, 2023 (estimated)
Last update
Mar 15, 2023

Study contacts

Hyo-Seok Na, MD., PhD.
Contact
hsknana@gmail.com
82317877507
Hyo-Seok Na, MD., PhD.
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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