Back to resultsThe Effect of Various External Pressure on Blood (EPB)
Primary Purpose
Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Auto PC(Acemedical, Goyang-si, Korea) - 0mmHg(control)
Auto PC(Acemedical, Goyang-si, Korea) - 150mmHg
Auto PC(Acemedical, Goyang-si, Korea) - 200mmHg
Auto PC(Acemedical, Goyang-si, Korea) - 250mmHg
Auto PC(Acemedical, Goyang-si, Korea) - 300mmHg
Sponsored by
About this trial
This is an interventional supportive care trial for Hemorrhage
Eligibility Criteria
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
Sites / Locations
- Korea university anam hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
5days
35days
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Hemolysis and alteration of deformability of red blood cell caused by external pressure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02520999
Brief Title
The Effect of Various External Pressure on Blood
Acronym
EPB
Official Title
Comparison of the Effect of Various External Pressure on Blood During Rapid Infusion
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hyub Huh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5days
Arm Type
Active Comparator
Arm Description
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.
Arm Title
35days
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Auto PC(Acemedical, Goyang-si, Korea) - 0mmHg(control)
Intervention Description
Blood pass through infusion set without external pressure.
Intervention Type
Device
Intervention Name(s)
Auto PC(Acemedical, Goyang-si, Korea) - 150mmHg
Intervention Description
Blood pass through infusion set under external pressure (150mmHg)
Intervention Type
Device
Intervention Name(s)
Auto PC(Acemedical, Goyang-si, Korea) - 200mmHg
Intervention Description
Blood pass through infusion set under external pressure (200mmHg)
Intervention Type
Device
Intervention Name(s)
Auto PC(Acemedical, Goyang-si, Korea) - 250mmHg
Intervention Description
Blood pass through infusion set under external pressure (250mmHg)
Intervention Type
Device
Intervention Name(s)
Auto PC(Acemedical, Goyang-si, Korea) - 300mmHg
Intervention Description
Blood pass through infusion set under external pressure (300mmHg)
Primary Outcome Measure Information:
Title
Hemolysis and alteration of deformability of red blood cell caused by external pressure
Time Frame
1hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyub Huh, M.D.
Organizational Affiliation
Department of anesthesiology and pain medicine, Korea University Anam Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Korea university anam hospital
City
Seoul
ZIP/Postal Code
136705
Country
Korea, Republic of
12. IPD Sharing Statement
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The Effect of Various External Pressure on Blood
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