Irrigating Fluid and Blood Coagulation

NCT ID: NCT03105180

Last Updated: 2017-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-10

Study Completion Date

2017-03-29

Brief Summary

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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 (ROTEMĀ®) tests.

Detailed Description

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Conditions

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Blood Coagulation Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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0% dilution

Blood specimen which was diluted with 0% level using a mixture of 2.7% sorbitol-0.54% mannitol solution

No interventions assigned to this group

10% dilution

Blood specimen which was diluted with 10% level using a mixture of 2.7% sorbitol-0.54% mannitol solution

A mixture of 2.7% sorbitol-0.54% mannitol solution

Intervention Type OTHER

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.

20% dilution

Blood specimen which was diluted with 20% level using a mixture of 2.7% sorbitol-0.54% mannitol solution

A mixture of 2.7% sorbitol-0.54% mannitol solution

Intervention Type OTHER

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.

40% dilution

Blood specimen which was diluted with 40% level using a mixture of 2.7% sorbitol-0.54% mannitol solution

A mixture of 2.7% sorbitol-0.54% mannitol solution

Intervention Type OTHER

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.

Interventions

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A mixture of 2.7% sorbitol-0.54% mannitol solution

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* age: 20 to 65 years
* Body weight \> 50 kg
* Volunteers who provided informed consent

Exclusion Criteria

* Hematologic disease
* Anticoagulant medication
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyo-Seok Na, PhD

Role: STUDY_CHAIR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1703/386-303

Identifier Type: -

Identifier Source: org_study_id

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