Plasmalyte-148 Solution and Blood Coagulation

Completed

• Conditions: Blood Coagulation Disorder
• Interventions: Other: Plasmalyte-148

• Registration Number: NCT03168087
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Primary Completion: 2018-08-23
• Study Completion: 2018-08-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
20% dilution	Plasmalyte-148	Blood specimen which was diluted with 20% level using a plasmalyte-148 solution
40% dilution	Plasmalyte-148	Blood specimen which was diluted with 40% level using a plasmalyte-148 solution
60% dilution	Plasmalyte-148	Blood specimen which was diluted with 60% level using a plasmalyte-148 solution

Primary Outcome Measures

Name	Time	Method
FIBTEM	During the rotational thromboelastometry analysis/ an average of 1 hour	Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym.

Secondary Outcome Measures

Name	Time	Method
INTEM	During the rotational thromboelastometry analysis/ an average of 1 hour	Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is not an acronym.
EMTEM	During the rotational thromboelastometry analysis/ an average of 1 hour	Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is not an acronym.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of