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Plasmalyte-148 Solution and Blood Coagulation

The Effect of a Plasmalyte-148 Solution on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03168087
Enrollment
12
Registered
2017-05-30
Start date
2017-05-15
Completion date
2018-08-30
Last updated
2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Coagulation Disorder

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.

Interventions

OTHERPlasmalyte-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.

Sponsors

Seoul National University Bundang Hospital
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Hematologic disease * Anticoagulant medication

Design outcomes

Primary

MeasureTime frameDescription
FIBTEMDuring the rotational thromboelastometry analysis/ an average of 1 hourFibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym.

Secondary

MeasureTime frameDescription
INTEMDuring the rotational thromboelastometry analysis/ an average of 1 hourIntrinsic pathway values of rotational thromboelastometry analysis/ INTEM is not an acronym.
EMTEMDuring the rotational thromboelastometry analysis/ an average of 1 hourExtrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is not an acronym.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026