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The Effect of Various External Pressure on Blood

NCT ID: NCT02520999

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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5days

5 days after blood sampling, various external pressure test will be done. Blood wil be stored in refrigerator(Celsius 4 degree) until study day. External pressure 0, 100, 150, 200, 250, 300mmHg will be applied to each blood sample.

Group Type ACTIVE_COMPARATOR

Auto PC(Acemedical, Goyang-si, Korea) - 0mmHg(control)

Intervention Type DEVICE

Blood pass through infusion set without external pressure.

Auto PC(Acemedical, Goyang-si, Korea) - 150mmHg

Intervention Type DEVICE

Blood pass through infusion set under external pressure (150mmHg)

Auto PC(Acemedical, Goyang-si, Korea) - 200mmHg

Intervention Type DEVICE

Blood pass through infusion set under external pressure (200mmHg)

Auto PC(Acemedical, Goyang-si, Korea) - 250mmHg

Intervention Type DEVICE

Blood pass through infusion set under external pressure (250mmHg)

Auto PC(Acemedical, Goyang-si, Korea) - 300mmHg

Intervention Type DEVICE

Blood pass through infusion set under external pressure (300mmHg)

35days

35 days after blood sampling, various external pressure test will be done. Blood wil be stored in refrigerator(Celsius 4 degree) until study day. External pressure 0, 100, 150, 200, 250, 300mmHg will be applied to each blood sample.

Group Type ACTIVE_COMPARATOR

Auto PC(Acemedical, Goyang-si, Korea) - 0mmHg(control)

Intervention Type DEVICE

Blood pass through infusion set without external pressure.

Auto PC(Acemedical, Goyang-si, Korea) - 150mmHg

Intervention Type DEVICE

Blood pass through infusion set under external pressure (150mmHg)

Auto PC(Acemedical, Goyang-si, Korea) - 200mmHg

Intervention Type DEVICE

Blood pass through infusion set under external pressure (200mmHg)

Auto PC(Acemedical, Goyang-si, Korea) - 250mmHg

Intervention Type DEVICE

Blood pass through infusion set under external pressure (250mmHg)

Auto PC(Acemedical, Goyang-si, Korea) - 300mmHg

Intervention Type DEVICE

Blood pass through infusion set under external pressure (300mmHg)

Interventions

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Auto PC(Acemedical, Goyang-si, Korea) - 0mmHg(control)

Blood pass through infusion set without external pressure.

Intervention Type DEVICE

Auto PC(Acemedical, Goyang-si, Korea) - 150mmHg

Blood pass through infusion set under external pressure (150mmHg)

Intervention Type DEVICE

Auto PC(Acemedical, Goyang-si, Korea) - 200mmHg

Blood pass through infusion set under external pressure (200mmHg)

Intervention Type DEVICE

Auto PC(Acemedical, Goyang-si, Korea) - 250mmHg

Blood pass through infusion set under external pressure (250mmHg)

Intervention Type DEVICE

Auto PC(Acemedical, Goyang-si, Korea) - 300mmHg

Blood pass through infusion set under external pressure (300mmHg)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hyub Huh

OTHER

Sponsor Role lead

Responsible Party

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Hyub Huh

M.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hyub Huh, M.D.

Role: STUDY_DIRECTOR

Department of anesthesiology and pain medicine, Korea University Anam Hospital

Locations

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Korea university anam hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BP300

Identifier Type: -

Identifier Source: org_study_id