Blood Coagulation DisorderNCT03105180
Irrigating Fluid 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
Irrigating fluid absorbed during the endoscopic surgery may alter whole blood coagulation. However, little is known about the dose-response relationships of hemodilution. The investigators have therefore performed the present study to measure the effect of a mixture of 2.7% sorbitol-0.54% mannitol solution on 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?
- A mixture of 2.7% sorbitol-0.54% mannitol solution
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Mar 2017to 29 Mar 2017
- 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, 463-707
About this study
Official title: The Effect of a Mixture of 2.7% Sorbitol-0.54% Mannitol Solution on Blood Coagulation: In-vitro, Observational Healthy-volunteer Study Using Rotational Thromboelastometry (ROTEM®)
Irrigating fluid absorbed during the endoscopic surgery may alter whole blood coagulation. However, little is known about the dose-response relationships of hemodilution. The investigators have therefore performed the present study to measure the effect of a mixture of 2.7% sorbitol-0.54% mannitol solution on the coagulation pathway according to the hemodilution level using a rotational thromboelastometry (ROTEM®) tests.
- Conditions
- Blood Coagulation Disorder
- Being tested
- A mixture of 2.7% sorbitol-0.54% mannitol solution
- 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.
A mixture of 2.7% sorbitol-0.54% mannitol solutionOther
Venous blood was taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 10%, 20%, and 40%) using a mixture of 2.7% sorbitol-0.54% mannitol solution.
| Study group | Role | What they receive |
|---|---|---|
| 0% dilution | Blood specimen which was diluted with 0% level using a mixture of 2.7% sorbitol-0.54% mannitol solution | |
| 10% dilution | Blood specimen which was diluted with 10% level using a mixture of 2.7% sorbitol-0.54% mannitol solution Receives: Other: A mixture of 2.7% sorbitol-0.54% mannitol solution | |
| 20% dilution | Blood specimen which was diluted with 20% level using a mixture of 2.7% sorbitol-0.54% mannitol solution Receives: Other: A mixture of 2.7% sorbitol-0.54% mannitol solution | |
| 40% dilution | Blood specimen which was diluted with 40% level using a mixture of 2.7% sorbitol-0.54% mannitol solution Receives: Other: A mixture of 2.7% sorbitol-0.54% mannitol solution |
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 s a proper noun which means the status of fibrinolytic coagulation pathway.
Measured: during the rotational thromboelastometry analysis/ an average of 1 hour
Secondary outcomes (2)
INTEM
Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is a proper noun which means the status of intrinsic coagulation pathway.
Measured: during the rotational thromboelastometry analysis/ an average of 1 hour
EXTEM
Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is a proper noun which means the status of extrinsic coagulation pathway.
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 posted7 Apr 2017
- Study start10 Mar 2017
- Primary completion29 Mar 2017
- Study completion29 Mar 2017
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.
- 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
- 12 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, PhD, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105180
- Sponsor's protocol ID
- B-1703/386-303
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Mixture of 2.7% Sorbitol-0.54% Mannitol Solution on Blood Coagulation: In-vitro, Observational Healthy-volunteer Study Using Rotational Thromboelastometry (ROTEM®)
- ClinicalTrials.gov ID
- NCT03105180
- Acronym / sponsor ID
- B-1703/386-303
- Conditions
- Blood Coagulation Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 7 Apr 2017 (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.
Irrigating fluid absorbed during the endoscopic surgery may alter whole blood coagulation. However, little is known about the dose-response relationships of hemodilution. The investigators have therefore performed the present study to measure the effect of a mixture of 2.7% sorbitol-0.54% mannitol solution on the coagulation pathway according to the hemodilution level using a rotational thromboelastometry (ROTEM®) tests.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0% dilution | – | –Blood specimen which was diluted with 0% level using a mixture of 2.7% sorbitol-0.54% mannitol solution |
| 10% dilution | – | Other: A mixture of 2.7% sorbitol-0.54% mannitol solutionBlood specimen which was diluted with 10% level using a mixture of 2.7% sorbitol-0.54% mannitol solution |
| 20% dilution | – | Other: A mixture of 2.7% sorbitol-0.54% mannitol solutionBlood specimen which was diluted with 20% level using a mixture of 2.7% sorbitol-0.54% mannitol solution |
| 40% dilution | – | Other: A mixture of 2.7% sorbitol-0.54% mannitol solutionBlood specimen which was diluted with 40% level using a mixture of 2.7% sorbitol-0.54% mannitol solution |
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 |
|---|---|---|
| A mixture of 2.7% sorbitol-0.54% mannitol solutionVenous blood was taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 10%, 20%, and 40%) using a mixture of 2.7% sorbitol-0.54% mannitol solution. | Other | 10% dilution, 20% dilution, 40% dilution |
Primary outcome
FIBTEM
Time frame: during the rotational thromboelastometry analysis/ an average of 1 hour
Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is s a proper noun which means the status of fibrinolytic coagulation pathway.
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 7 Apr 2017.
- Individual participant dataSharing planned: No
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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, PhD study chair
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 7 Apr 2017. 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?
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 7 Apr 2017.