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Completed

NCT Number: NCT03168087

Plasmalyte-148 Solution and Blood Coagulation

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.

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Key information

Conditions

Blood Coagulation Disorder Blood Coagulation Disorders Hematologic Diseases Hemic and Lymphatic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Hematologic disease
  • Anticoagulant medication

Treatment and study plan

Plasmalyte-148

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 30, 2017
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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