Plasmalyte-148 Solution and Blood Coagulation

NCT ID: NCT03168087

Last Updated: 2020-02-13

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

2017-05-15

Study Completion Date

2018-08-30

Brief Summary

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Fluids administered intravenously may alter whole blood coagulation. However, little is known about the dose-response relationships of hemodilution in plasmalyte-148 solution. Investigators have therefore performed the present study to measure the effect of a plasmalyte-148 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 plasmalyte-148 solution

No interventions assigned to this group

20% dilution

Blood specimen which was diluted with 20% level using a plasmalyte-148 solution

Plasmalyte-148

Intervention Type OTHER

Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 20%, 40%, and 60%) using a plasmalyte-148 solution.

40% dilution

Blood specimen which was diluted with 40% level using a plasmalyte-148 solution

Plasmalyte-148

Intervention Type OTHER

Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 20%, 40%, and 60%) using a plasmalyte-148 solution.

60% dilution

Blood specimen which was diluted with 60% level using a plasmalyte-148 solution

Plasmalyte-148

Intervention Type OTHER

Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 20%, 40%, and 60%) using a plasmalyte-148 solution.

Interventions

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Plasmalyte-148

Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 20%, 40%, and 60%) using a plasmalyte-148 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 collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyun-Jung Shin

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun-Jung Shin, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1705/395-303

Identifier Type: -

Identifier Source: org_study_id

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