NCT02639780

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

3.9 years

First QC Date

December 21, 2015

Last Update Submit

January 1, 2022

Conditions

Coagulation

Outcome Measures

Primary Outcomes (4)

  • protein expression pattern

    week 0

  • protein expression pattern

    week 2

  • protein expression pattern

    week 4

  • protein expression pattern

    week 6

Study Arms (6)

healthy young female

Other: protein expression pattern of packed red blood cells

healthy young male

Other: protein expression pattern of packed red blood cells

healthy older female

Other: protein expression pattern of packed red blood cells

healthy older male

Other: protein expression pattern of packed red blood cells

obese older female

Other: protein expression pattern of packed red blood cells

obese older male

Other: protein expression pattern of packed red blood cells

Interventions

protein expression pattern of packed red blood cellsOTHER

the proteome of packed red blood cells will be assessed at predefined time points

healthy older femalehealthy older malehealthy young femalehealthy young maleobese older femaleobese older male

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

volunteers who will donate one unit of packed red blood cells

You may qualify if:

  • 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

You may not qualify if:

  • age below 18 years
  • age above 60 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

packed red blood cells

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 21, 2015

First Posted

December 24, 2015

Study Start

December 1, 2015

Primary Completion

November 1, 2019

Study Completion

December 1, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)