Plasmalyte-148 Solution and Blood Coagulation

Blood Coagulation Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03168087
• Other study ID #: B-1705/395-303
• Status: Completed
• Start date: May 15, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: February 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 30, 2018
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Age: 20 to 65 years

• Body weight > 50 kg

• Volunteers who provided informed consent

Exclusion Criteria:

• Hematologic disease

• Anticoagulant medication

Related Conditions & MeSH terms

• Blood Coagulation Disorder
• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FIBTEM	Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym.	During the rotational thromboelastometry analysis/ an average of 1 hour
Secondary	INTEM	Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is not an acronym.	During the rotational thromboelastometry analysis/ an average of 1 hour
Secondary	EMTEM	Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is not an acronym.	During the rotational thromboelastometry analysis/ an average of 1 hour