- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02520999
The Effect of Various External Pressure on Blood (EPB)
November 25, 2015 updated by: Hyub Huh
Comparison of the Effect of Various External Pressure on Blood During Rapid Infusion
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 136705
- Korea University Anam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
Blood pass through infusion set without external pressure.
Blood pass through infusion set under external pressure (150mmHg)
Blood pass through infusion set under external pressure (200mmHg)
Blood pass through infusion set under external pressure (250mmHg)
Blood pass through infusion set under external pressure (300mmHg)
|
|
Active Comparator: 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.
|
Blood pass through infusion set without external pressure.
Blood pass through infusion set under external pressure (150mmHg)
Blood pass through infusion set under external pressure (200mmHg)
Blood pass through infusion set under external pressure (250mmHg)
Blood pass through infusion set under external pressure (300mmHg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hemolysis and alteration of deformability of red blood cell caused by external pressure
Time Frame: 1hour
|
1hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hyub Huh, M.D., Department of anesthesiology and pain medicine, Korea University Anam Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
August 4, 2015
First Submitted That Met QC Criteria
August 7, 2015
First Posted (Estimate)
August 13, 2015
Study Record Updates
Last Update Posted (Estimate)
November 30, 2015
Last Update Submitted That Met QC Criteria
November 25, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP300
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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