Irrigating Fluid and Blood Coagulation

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®)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03105180

Enrollment

Registered

2017-04-07

Start date

2017-03-10

Completion date

2017-03-29

Last updated

2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Coagulation Disorder

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.

Interventions

OTHERA 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.

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers * age: 20 to 65 years * Body weight \> 50 kg * Volunteers who provided informed consent

Exclusion criteria

* Hematologic disease * Anticoagulant medication

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026