Irrigating Fluid and Blood Coagulation

Blood Coagulation Disorder Clinical Trial

Official title:

The Effect of a Mixture of 2.7% Sorbitol-0.54% Mannitol Solution on Blood Coagulation: In-vitro, Observational Healthy-volunteer Study Using Rotational Thromboelastometry (ROTEM®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105180
• Other study ID #: B-1703/386-303
• Status: Completed
• Phase: N/A
• First received: March 29, 2017
• Last updated: April 3, 2017
• Start date: March 10, 2017
• Est. completion date: March 29, 2017

Study information

• Verified date: April 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• 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:
• A mixture of 2.7% sorbitol-0.54% mannitol solution
Venous blood was taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 10%, 20%, and 40%) using a mixture of 2.7% sorbitol-0.54% mannitol solution.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
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 s a proper noun which means the status of fibrinolytic coagulation pathway.	during the rotational thromboelastometry analysis/ an average of 1 hour
Secondary	INTEM	Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is a proper noun which means the status of intrinsic coagulation pathway.	during the rotational thromboelastometry analysis/ an average of 1 hour
Secondary	EXTEM	Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is a proper noun which means the status of extrinsic coagulation pathway.	during the rotational thromboelastometry analysis/ an average of 1 hour