Irrigating Fluid and Blood Coagulation

NCT03105180 | Completed

• 1 other identifier: B-1703/386-303
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Coagulation Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• INTEM

  during the rotational thromboelastometry analysis/ an average of 1 hour

• EXTEM

  during the rotational thromboelastometry analysis/ an average of 1 hour

Study Arms (4)

0% dilution

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

10% dilution

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

Other: A mixture of 2.7% sorbitol-0.54% mannitol solution

20% dilution

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

Other: A mixture of 2.7% sorbitol-0.54% mannitol solution

40% dilution

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

Other: A mixture of 2.7% sorbitol-0.54% mannitol solution

Interventions

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.

10% dilution; 20% dilution; 40% dilution

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

You may qualify if:

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

You may not qualify if:

• Hematologic disease
• Anticoagulant medication

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hyo-Seok Na, PhD

  Seoul National University Bundang Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 7, 2017
• Study Start: March 10, 2017
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)