Dexmedetomidine and Blood Coagulation

June 30, 2021 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

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

Dexmedetomidine may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of dexmedetomidine. The investigators have therefore performed the present study to measure the effect of dexmedetomidine on the coagulation pathway according to the drug concentration level using a rotational thromboelastometry test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Hematologic disease
  • Anticoagulant medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
0 ng/ml
Blood specimen which was added 0 ul of dexmedetomidine
Drug: 0 ul of dexmedetomidine
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using dexmedetomidine
0.5 ng/ml
Blood specimen which was added 0.25 ul of dexmedetomidine
Drug: 0.25 ul of dexmedetomidine
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.25 ul) using dexmedetomidine
1.0 ng/ml
Blood specimen which was added 0.5 ul of dexmedetomidine
Drug: 0.5 ul of dexmedetomidine
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.5 ul) using dexmedetomidine
1.5 ng/ml
Blood specimen which was added 0.75 ul of dexmedetomidine
Drug: 0.75 ul of dexmedetomidine
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.75 ul) using dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FIBTEM
Time Frame: During the rotational thromboelastometry analysis/ an average of 1 hour
Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym.
During the rotational thromboelastometry analysis/ an average of 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
INTEM
Time Frame: During the rotational thromboelastometry analysis/ an average of 1 hour
Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is not an acronym.
During the rotational thromboelastometry analysis/ an average of 1 hour
EXTEM
Time Frame: During the rotational thromboelastometry analysis/ an average of 1 hour
Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is not an acronym.
During the rotational thromboelastometry analysis/ an average of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 12, 2020

Primary Completion (ACTUAL)

December 30, 2020

Study Completion (ACTUAL)

December 30, 2020

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (ACTUAL)

February 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2002/595-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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