NCT02520999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

3 months

First QC Date

August 4, 2015

Last Update Submit

November 25, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hemolysis and alteration of deformability of red blood cell caused by external pressure

    1hour

Study Arms (2)

5days

ACTIVE COMPARATOR

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.

Device: Auto PC(Acemedical, Goyang-si, Korea) - 0mmHg(control)Device: Auto PC(Acemedical, Goyang-si, Korea) - 150mmHgDevice: Auto PC(Acemedical, Goyang-si, Korea) - 200mmHgDevice: Auto PC(Acemedical, Goyang-si, Korea) - 250mmHgDevice: Auto PC(Acemedical, Goyang-si, Korea) - 300mmHg

35days

ACTIVE COMPARATOR

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.

Device: Auto PC(Acemedical, Goyang-si, Korea) - 0mmHg(control)Device: Auto PC(Acemedical, Goyang-si, Korea) - 150mmHgDevice: Auto PC(Acemedical, Goyang-si, Korea) - 200mmHgDevice: Auto PC(Acemedical, Goyang-si, Korea) - 250mmHgDevice: Auto PC(Acemedical, Goyang-si, Korea) - 300mmHg

Interventions

Blood pass through infusion set without external pressure.

35days5days

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

35days5days

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

35days5days

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

35days5days

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

35days5days

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers, without any underlying disease.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea university anam hospital

Seoul, 136705, South Korea

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hyub Huh, M.D.

    Department of anesthesiology and pain medicine, Korea University Anam Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 13, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 30, 2015

Record last verified: 2015-11

Locations