Irrigating Fluid and Blood Coagulation

Completed

• Conditions: Blood Coagulation Disorder
• Interventions: Other: A mixture of 2.7% sorbitol-0.54% mannitol solution

• Registration Number: NCT03105180
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Irrigating fluid absorbed during the endoscopic surgery may alter whole blood coagulation. However, little is known about the dose-response relationships of hemodilution. The investigators have therefore performed the present study to measure the effect of a mixture of 2.7% sorbitol-0.54% mannitol solution on the coagulation pathway according to the hemodilution level using a rotational thromboelastometry (ROTEM®) tests.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-10
• Primary Completion: 2017-03-29
• Study Completion: 2017-03-29
• Study First Submitted: 2017-03-29
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-03
• Last Update Submitted: 2017-04-03
• Study First Posted: 2017-04-07
• Last Update Posted: 2017-04-07

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
10% dilution	A mixture of 2.7% sorbitol-0.54% mannitol solution	Blood specimen which was diluted with 10% level using a mixture of 2.7% sorbitol-0.54% mannitol solution
20% dilution	A mixture of 2.7% sorbitol-0.54% mannitol solution	Blood specimen which was diluted with 20% level using a mixture of 2.7% sorbitol-0.54% mannitol solution
40% dilution	A mixture of 2.7% sorbitol-0.54% mannitol solution	Blood specimen which was diluted with 40% level using a mixture of 2.7% sorbitol-0.54% mannitol 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 s a proper noun which means the status of fibrinolytic coagulation pathway.

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 a proper noun which means the status of intrinsic coagulation pathway.
EXTEM	during the rotational thromboelastometry analysis/ an average of 1 hour	Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is a proper noun which means the status of extrinsic coagulation pathway.

Trial Locations

Locations (1)

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