Plasmalyte-148 Solution and Blood Coagulation
The Effect of a Plasmalyte-148 Solution on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry
1 other identifier
observational
12
1 country
1
Brief Summary
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 (ROTEM®) tests.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2017
CompletedFirst Submitted
Initial submission to the registry
May 24, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2018
CompletedFebruary 13, 2020
February 1, 2020
1.3 years
May 24, 2017
February 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
FIBTEM
Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym.
During the rotational thromboelastometry analysis/ an average of 1 hour
Secondary Outcomes (2)
INTEM
During the rotational thromboelastometry analysis/ an average of 1 hour
EMTEM
During the rotational thromboelastometry analysis/ an average of 1 hour
Study Arms (4)
0% dilution
Blood specimen which was diluted with 0% level using a plasmalyte-148 solution
20% dilution
Blood specimen which was diluted with 20% level using a plasmalyte-148 solution
40% dilution
Blood specimen which was diluted with 40% level using a plasmalyte-148 solution
60% dilution
Blood specimen which was diluted with 60% level using a plasmalyte-148 solution
Interventions
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.
Eligibility Criteria
Healthy volunteers
You may qualify if:
- Healthy volunteers
- Age: 20 to 65 years
- Body weight \> 50 kg
- Volunteers who provided informed consent
You may not qualify if:
- Hematologic disease
- Anticoagulant medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyun-Jung Shin, PhD
Seoul National University Bundang Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
May 24, 2017
First Posted
May 30, 2017
Study Start
May 15, 2017
Primary Completion
August 23, 2018
Study Completion
August 30, 2018
Last Updated
February 13, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share