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Biochemical Alterations of Stored Erythrocyte Membranes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639780
Recruitment Status : Active, not recruiting
First Posted : December 24, 2015
Last Update Posted : November 22, 2019
Sponsor:
Collaborators:
Medical Scientific Fund of the Mayor of Vienna
European Society of Anaesthesiology
Information provided by (Responsible Party):
David M Baron, MD, Medical University of Vienna

Brief Summary:
The investigators will define procoagulant properties of packed red blood cells and investigate whether packed red blood cells from certain donor populations are prone to induce procoagulant states.

Condition or disease Intervention/treatment
Coagulation Other: protein expression pattern of packed red blood cells

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biochemical Alterations of Stored Erythrocyte Membranes
Study Start Date : December 2015
Actual Primary Completion Date : November 2019
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
healthy young female Other: protein expression pattern of packed red blood cells
the proteome of packed red blood cells will be assessed at predefined time points

healthy young male Other: protein expression pattern of packed red blood cells
the proteome of packed red blood cells will be assessed at predefined time points

healthy older female Other: protein expression pattern of packed red blood cells
the proteome of packed red blood cells will be assessed at predefined time points

healthy older male Other: protein expression pattern of packed red blood cells
the proteome of packed red blood cells will be assessed at predefined time points

obese older female Other: protein expression pattern of packed red blood cells
the proteome of packed red blood cells will be assessed at predefined time points

obese older male Other: protein expression pattern of packed red blood cells
the proteome of packed red blood cells will be assessed at predefined time points




Primary Outcome Measures :
  1. protein expression pattern [ Time Frame: week 0 ]
  2. protein expression pattern [ Time Frame: week 2 ]
  3. protein expression pattern [ Time Frame: week 4 ]
  4. protein expression pattern [ Time Frame: week 6 ]

Biospecimen Retention:   Samples Without DNA
packed red blood cells


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
volunteers who will donate one unit of packed red blood cells
Criteria

Inclusion Criteria:

  • group 1: healthy female volunteers 18-35 y.o.
  • group 2: healthy male volunteers 18-35 y.o.
  • group 3: healthy female volunteers 36-60 y.o.
  • group 4: healthy male volunteers 36-60 y.o.
  • group 5: female volunteers 36-60 y.o., BMI 26-45
  • group 6: male volunteers 36-60 y.o., BMI 26-45

Exclusion Criteria:

  • age below 18 years
  • age above 60 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639780


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Medical Scientific Fund of the Mayor of Vienna
European Society of Anaesthesiology
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Responsible Party: David M Baron, MD, Assistant Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02639780    
Other Study ID Numbers: 1043/2015
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No