Blood Coagulation DisorderNCT04507711
Palonosetron and Blood Coagulation
A study testing 0 ul of palonosetron, 1 ul of palonosetron and 10 ul of palonosetron in people with Blood Coagulation Disorder, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Palonosetron may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of palonosetron. The investigators therefore will perform the present study to measure the effect of palonosetron levels using thromboelastography. 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 palonosetron, 1 ul of palonosetron and 10 ul of palonosetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Sep 2020to 15 Dec 2023
- Phase
- Interventional
- 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
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, 1 recruiting
- Recruiting
Seoul National Univ. Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Hyo-Seok Na, 1087012913, hsknana@gmail.com
About this study
Official title: The Effect of a Palonosetron on Blood Coagulation: In Vitro, Volunteer Study Using Thromboelastography
Palonosetron may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of palonosetron. The investigators therefore will perform the present study to measure the effect of palonosetron levels using thromboelastography.
- Conditions
- Blood Coagulation Disorder
- Being tested
- 0 ul of palonosetron, 1 ul of palonosetron, 10 ul of palonosetron, 100 ul of palonosetron
- 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 palonosetronDrug
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using palonosetron
1 ul of palonosetronDrug
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (1 ul) using palonosetron
10 ul of palonosetronDrug
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (10 ul) using palonosetron
100 ul of palonosetronDrug
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (100 ul) using palonosetron
| Study group | Role | What they receive |
|---|---|---|
| 0 ng/ml | Experimental | Blood specimen which was added of 0 ul of palonosetron Receives: Drug: 0 ul of palonosetron |
| 25 ng/ml | Experimental | Blood specimen which was added of 1 ul of palonosetron Receives: Drug: 1 ul of palonosetron |
| 250 ng/ml | Experimental | Blood specimen which was added of 10 ul of palonosetron Receives: Drug: 10 ul of palonosetron |
| 2500 ng/ml | Experimental | Blood specimen which was added of 100 ul of palonosetron Receives: Drug: 100 ul of palonosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Citrated Functional Fibrinogen
Provides clot strength based on fibrinogen contribution
Measured: During the thromboelastography analysis/ an average of 1 hour
Secondary outcomes (7)
Citrated Kaolin
Normal thromboelastography
Measured: During the thromboelastography analysis/ an average of 1 hour
Citrated Kaolin Heparinase
To assess the effect of heparin
Measured: During the thromboelastography analysis/ an average of 1 hour
Citrated Rapid Thromboelastography
A quicker assessment of clot strength, without assessment of clot initiation
Measured: During the thromboelastography analysis/ an average of 1 hour
Heparinized Kaloin Heprinase
To measure the platelet function
Measured: During the thromboelastography analysis/ an average of 1 hour
Activator F
To elimitate the platelt function
Measured: During the thromboelastography analysis/ an average of 1 hour
Adenosine diphosphate
To measure the drug effect
Measured: During the thromboelastography analysis/ an average of 1 hour
Arachidonic acid
To measure the drug effect
Measured: During the thromboelastography 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 posted11 Aug 2020
- Study start16 Sep 2020
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation DisorderStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
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
- NCT04507711
- Sponsor's protocol ID
- B-2002/631-304
- Status last verified
- Mar 2023
- First submitted
- 31 Jul 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Palonosetron on Blood Coagulation: In Vitro, Volunteer Study Using Thromboelastography
- ClinicalTrials.gov ID
- NCT04507711
- Acronym / sponsor ID
- B-2002/631-304
- Conditions
- Blood Coagulation Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 11 Aug 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.
Palonosetron may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of palonosetron. The investigators therefore will perform the present study to measure the effect of palonosetron levels using thromboelastography.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 ng/ml | Experimental | Drug: 0 ul of palonosetronBlood specimen which was added of 0 ul of palonosetron |
| 25 ng/ml | Experimental | Drug: 1 ul of palonosetronBlood specimen which was added of 1 ul of palonosetron |
| 250 ng/ml | Experimental | Drug: 10 ul of palonosetronBlood specimen which was added of 10 ul of palonosetron |
| 2500 ng/ml | Experimental | Drug: 100 ul of palonosetronBlood specimen which was added of 100 ul of palonosetron |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 palonosetronVenous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using palonosetron | Drug | 0 ng/ml |
| 1 ul of palonosetronVenous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (1 ul) using palonosetron | Drug | 25 ng/ml |
| 10 ul of palonosetronVenous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (10 ul) using palonosetron | Drug | 250 ng/ml |
| 100 ul of palonosetronVenous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (100 ul) using palonosetron | Drug | 2500 ng/ml |
Primary outcome
Citrated Functional Fibrinogen
Time frame: During the thromboelastography analysis/ an average of 1 hour
Provides clot strength based on fibrinogen contribution
7 secondary outcomes
Citrated Kaolin
Time frame: During the thromboelastography analysis/ an average of 1 hour
Citrated Kaolin Heparinase
Time frame: During the thromboelastography analysis/ an average of 1 hour
Citrated Rapid Thromboelastography
Time frame: During the thromboelastography analysis/ an average of 1 hour
Heparinized Kaloin Heprinase
Time frame: During the thromboelastography analysis/ an average of 1 hour
Activator F
Time frame: During the thromboelastography analysis/ an average of 1 hour
Adenosine diphosphate
Time frame: During the thromboelastography analysis/ an average of 1 hour
Arachidonic acid
Time frame: During the thromboelastography analysis/ an average of 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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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?
A study testing 0 ul of palonosetron, 1 ul of palonosetron and 10 ul of palonosetron in people with 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyo-Seok Na, MD., PhD. (82317877507, hsknana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Citrated Functional Fibrinogen (time frame: During the thromboelastography 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?
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 15 Mar 2023.