Blood Coagulation DisorderNCT04269278
Dexmedetomidine and Blood Coagulation
An observational study of Blood Coagulation Disorder, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Coagulation Disorder
- What is being tested?
- 0 ul of dexmedetomidine, 0.25 ul of dexmedetomidine and 0.5 ul of dexmedetomidine
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Feb 2020to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Healthy volunteers
- Age: 20 to 65 years
- Body weight > 50 kg
- Volunteers who provided informed consent
Who cannot join
- Hematologic disease
- Anticoagulant medication
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: 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.
- Conditions
- Blood Coagulation Disorder
- Being tested
- 0 ul of dexmedetomidine, 0.25 ul of dexmedetomidine, 0.5 ul of dexmedetomidine, 0.75 ul of dexmedetomidine
- Medical subject headings
- Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 ul of dexmedetomidineDrug
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using dexmedetomidine
0.25 ul of dexmedetomidineDrug
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
0.5 ul of dexmedetomidineDrug
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
0.75 ul of dexmedetomidineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 0 ng/ml | Blood specimen which was added 0 ul of dexmedetomidine Receives: Drug: 0 ul of dexmedetomidine | |
| 0.5 ng/ml | Blood specimen which was added 0.25 ul of dexmedetomidine Receives: Drug: 0.25 ul of dexmedetomidine | |
| 1.0 ng/ml | Blood specimen which was added 0.5 ul of dexmedetomidine Receives: Drug: 0.5 ul of dexmedetomidine | |
| 1.5 ng/ml | Blood specimen which was added 0.75 ul of dexmedetomidine Receives: Drug: 0.75 ul of dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIBTEM
Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym.
Measured: During the rotational thromboelastometry analysis/ an average of 1 hour
Secondary outcomes (2)
INTEM
Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is not an acronym.
Measured: During the rotational thromboelastometry analysis/ an average of 1 hour
EXTEM
Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is not an acronym.
Measured: During the rotational thromboelastometry analysis/ an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start12 Feb 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Coagulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
- Investigators
- Hyo-Seok Na, MD., PhD., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269278
- Sponsor's protocol ID
- B-2002/595-301
- Status last verified
- Jun 2021
- First submitted
- 11 Feb 2020
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34268623
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry
- ClinicalTrials.gov ID
- NCT04269278
- Acronym / sponsor ID
- B-2002/595-301
- Conditions
- Blood Coagulation Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 ng/ml | – | Drug: 0 ul of dexmedetomidineBlood specimen which was added 0 ul of dexmedetomidine |
| 0.5 ng/ml | – | Drug: 0.25 ul of dexmedetomidineBlood specimen which was added 0.25 ul of dexmedetomidine |
| 1.0 ng/ml | – | Drug: 0.5 ul of dexmedetomidineBlood specimen which was added 0.5 ul of dexmedetomidine |
| 1.5 ng/ml | – | Drug: 0.75 ul of dexmedetomidineBlood specimen which was added 0.75 ul of dexmedetomidine |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (4 listed)
- Healthy volunteers
- Age: 20 to 65 years
- Body weight > 50 kg
- Volunteers who provided informed consent
Key exclusion criteria (2 listed)
- Hematologic disease
- Anticoagulant medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0 ul of dexmedetomidineVenous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using dexmedetomidine | Drug | 0 ng/ml |
| 0.25 ul of dexmedetomidineVenous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.25 ul) using dexmedetomidine | Drug | 0.5 ng/ml |
| 0.5 ul of dexmedetomidineVenous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.5 ul) using dexmedetomidine | Drug | 1.0 ng/ml |
| 0.75 ul of dexmedetomidineVenous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.75 ul) using dexmedetomidine | Drug | 1.5 ng/ml |
Primary outcome
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.
2 secondary outcomes
INTEM
Time frame: During the rotational thromboelastometry analysis/ an average of 1 hour
EXTEM
Time frame: During the rotational thromboelastometry analysis/ an average of 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Derived from this study: PubMed 34268623Shin 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.
Related trials for Blood Coagulation Disorder
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 3
A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia
Essential Thrombocythemia
RecruitingPhase 1
Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Myeloproliferative Neoplasms
Not yet recruitingPhase 1
Lentiviral FVIII Gene Therapy
Hemophilia A
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyo-Seok Na, MD., PhD. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Coagulation Disorder, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIBTEM (time frame: During the rotational thromboelastometry analysis/ an average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04269278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.