- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03168087
Plasmalyte-148 Solution and Blood Coagulation
February 11, 2020 updated by: Hyun-Jung Shin, Seoul National University Hospital
The Effect of a Plasmalyte-148 Solution on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seongnam-si, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteers
Description
Inclusion Criteria:
- Healthy volunteers
- Age: 20 to 65 years
- Body weight > 50 kg
- Volunteers who provided informed consent
Exclusion Criteria:
- Hematologic disease
- Anticoagulant medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FIBTEM
Time Frame: During the rotational thromboelastometry analysis/ an average of 1 hour
|
Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym.
|
During the rotational thromboelastometry analysis/ an average of 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
INTEM
Time Frame: During the rotational thromboelastometry analysis/ an average of 1 hour
|
Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is not an acronym.
|
During the rotational thromboelastometry analysis/ an average of 1 hour
|
EMTEM
Time Frame: During the rotational thromboelastometry analysis/ an average of 1 hour
|
Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is not an acronym.
|
During the rotational thromboelastometry analysis/ an average of 1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Hyun-Jung Shin, PhD, Seoul National University Bundang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2017
Primary Completion (Actual)
August 23, 2018
Study Completion (Actual)
August 30, 2018
Study Registration Dates
First Submitted
May 24, 2017
First Submitted That Met QC Criteria
May 25, 2017
First Posted (Actual)
May 30, 2017
Study Record Updates
Last Update Posted (Actual)
February 13, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1705/395-303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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