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NCT02520999 Clinical Trial

The Effect of Various External Pressure on Blood

Hemorrhage Clinical Trial

— EPB  

Official title:
Comparison of the Effect of Various External Pressure on Blood During Rapid Infusion

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02520999
Other study ID # BP300
Secondary ID
Status Completed
Phase N/A
First received August 4, 2015
Last updated November 25, 2015
Start date August 2015
Est. completion date November 2015

Study information
Verified date November 2015
Source Korea University Anam Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Rapid infusion of blood is needed occasionally for control massive bleeding. For rapid infusion, external pressure can be used. The investigators will study correlation between external pressure and hemolysis and deformability of red blood cell.

Description:

Rapid infusion of blood is needed occasionally for control massive bleeding. For rapid infusion, external pressure can be used which cause hemolysis and alteration of red blood cell. The investigators will study correlation between variable external pressure and hemolysis and deformability of red blood cell. Differ from previous study, the investigator will use scanning electron microscope for observation red blood cell.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- healthy volunteers, without any underlying disease.

Exclusion Criteria:

- history of delivery, abortion in past 6 months.

- weight : male under 50kg, female under 45kg

- heart rate under 50 or over 100

- fever : over 37.5

- blood pressure : over 180/100

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Device:
• Auto PC(Acemedical, Goyang-si, Korea) - 0mmHg(control)
Blood pass through infusion set without external pressure.
• Auto PC(Acemedical, Goyang-si, Korea) - 150mmHg
Blood pass through infusion set under external pressure (150mmHg)
• Auto PC(Acemedical, Goyang-si, Korea) - 200mmHg
Blood pass through infusion set under external pressure (200mmHg)
• Auto PC(Acemedical, Goyang-si, Korea) - 250mmHg
Blood pass through infusion set under external pressure (250mmHg)
• Auto PC(Acemedical, Goyang-si, Korea) - 300mmHg
Blood pass through infusion set under external pressure (300mmHg)

Locations
Country Name City State
Korea, Republic of Korea university anam hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hyub Huh

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemolysis and alteration of deformability of red blood cell caused by external pressure 1hour No
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