Dexmedetomidine and Blood Coagulation
The Effect of Dexmedetomidine on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry
1 other identifier
observational
11
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2020
CompletedStudy Start
First participant enrolled
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedJuly 2, 2021
June 1, 2021
11 months
February 11, 2020
June 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
FIBTEM
Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym.
During the rotational thromboelastometry analysis/ an average of 1 hour
Secondary Outcomes (2)
INTEM
During the rotational thromboelastometry analysis/ an average of 1 hour
EXTEM
During the rotational thromboelastometry analysis/ an average of 1 hour
Study Arms (4)
0 ng/ml
Blood specimen which was added 0 ul of dexmedetomidine
0.5 ng/ml
Blood specimen which was added 0.25 ul of dexmedetomidine
1.0 ng/ml
Blood specimen which was added 0.5 ul of dexmedetomidine
1.5 ng/ml
Blood specimen which was added 0.75 ul of dexmedetomidine
Interventions
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using 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
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
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
Eligibility Criteria
Healthy volunteers
You may qualify if:
- Healthy volunteers
- Age: 20 to 65 years
- Body weight \> 50 kg
- Volunteers who provided informed consent
You may not qualify if:
- Hematologic disease
- Anticoagulant medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Related Publications (1)
Shin HJ, Boo G, Na HS. Effects of dexmedetomidine on blood coagulation: an in vitro study using rotational thromboelastometry. J Anesth. 2021 Oct;35(5):633-637. doi: 10.1007/s00540-021-02969-x. Epub 2021 Jul 15.
PMID: 34268623DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyo-Seok Na, MD., PhD.
Seoul National University Bundang Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 11, 2020
First Posted
February 13, 2020
Study Start
February 12, 2020
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
July 2, 2021
Record last verified: 2021-06