Biochemical Alterations of Stored Erythrocyte Membranes

January 1, 2022 updated by: David M Baron, MD, Medical University of Vienna
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

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

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

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

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

volunteers who will donate one unit of packed red blood cells

Description

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

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
protein expression pattern
Time Frame: week 0
week 0
protein expression pattern
Time Frame: week 2
week 2
protein expression pattern
Time Frame: week 4
week 4
protein expression pattern
Time Frame: week 6
week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

European Society of Anaesthesiology
Medical Scientific Fund of the Mayor of Vienna

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 (ACTUAL)

December 1, 2015

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

December 1, 2021

Study Registration Dates

First Submitted

December 21, 2015

First Submitted That Met QC Criteria

December 23, 2015

First Posted (ESTIMATE)

December 24, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 4, 2022

Last Update Submitted That Met QC Criteria

January 1, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 1043/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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