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Completed

NCT Number: NCT03105180

Irrigating Fluid and Blood Coagulation

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.

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Key information

Conditions

Blood Coagulation Disorder Blood Coagulation Disorders Hematologic Diseases Hemic and Lymphatic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Hematologic disease
  • Anticoagulant medication

Treatment and study plan

A mixture of 2.7% sorbitol-0.54% mannitol solution

Other

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.

Primary outcomes

  1. FIBTEM

    Time frame: 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 outcomes

  1. INTEM

    Time frame: 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.

  2. EXTEM

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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®)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2017
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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