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®)

Irrigating Fluid and Blood Coagulation

Sponsors

Lead sponsor: Seoul National University Bundang Hospital

Source 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.

Overall Status Completed
Start Date March 10, 2017
Completion Date March 29, 2017
Primary Completion Date March 29, 2017
Study Type Observational
Primary Outcome
Measure Time Frame
FIBTEM during the rotational thromboelastometry analysis/ an average of 1 hour
Secondary Outcome
Measure Time Frame
INTEM during the rotational thromboelastometry analysis/ an average of 1 hour
EXTEM during the rotational thromboelastometry analysis/ an average of 1 hour
Enrollment 12
Condition
Intervention

Intervention type: Other

Intervention name: A mixture of 2.7% sorbitol-0.54% mannitol solution

Description: 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.

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Healthy volunteers

- age: 20 to 65 years

- Body weight > 50 kg

- Volunteers who provided informed consent

Exclusion Criteria:

- Hematologic disease

- Anticoagulant medication

Gender: All

Minimum age: 20 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Hyo-Seok Na, PhD Study Chair Seoul National University Bundang Hospital
Location
facility Seoul National University Bundang Hospital
Location Countries

Korea, Republic of

Verification Date

April 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Seoul National University Bundang Hospital

Investigator full name: Hyo-Seok Na

Investigator title: Associate Professor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: 0% dilution

Description: Blood specimen which was diluted with 0% level using a mixture of 2.7% sorbitol-0.54% mannitol solution

Arm group label: 10% dilution

Description: Blood specimen which was diluted with 10% level using a mixture of 2.7% sorbitol-0.54% mannitol solution

Arm group label: 20% dilution

Description: Blood specimen which was diluted with 20% level using a mixture of 2.7% sorbitol-0.54% mannitol solution

Arm group label: 40% dilution

Description: Blood specimen which was diluted with 40% level using a mixture of 2.7% sorbitol-0.54% mannitol solution

Patient Data No
Study Design Info

Observational model: Case-Control

Time perspective: Cross-Sectional

Source: ClinicalTrials.gov