CoagulationNCT02639780
Biochemical Alterations of Stored Erythrocyte Membranes
An observational study of Coagulation, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Coagulation
- What is being tested?
- protein expression pattern of packed red blood cells
- How many people
- 36 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2015to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: volunteers who will donate one unit of packed red blood cells
Who may be able to join
- 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
Who cannot join
- age below 18 years
- age above 60 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Coagulation
- Being tested
- protein expression pattern of packed red blood cells
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein expression pattern of packed red blood cellsOther
the proteome of packed red blood cells will be assessed at predefined time points
| Study group | Role | What they receive |
|---|---|---|
| healthy young female | Not described Receives: Other: protein expression pattern of packed red blood cells | |
| healthy young male | Not described Receives: Other: protein expression pattern of packed red blood cells | |
| healthy older female | Not described Receives: Other: protein expression pattern of packed red blood cells | |
| healthy older male | Not described Receives: Other: protein expression pattern of packed red blood cells | |
| obese older female | Not described Receives: Other: protein expression pattern of packed red blood cells | |
| obese older male | Not described Receives: Other: protein expression pattern of packed red blood cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
protein expression pattern
Measured: week 0
protein expression pattern
Measured: week 2
protein expression pattern
Measured: week 4
protein expression pattern
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionNov 2019
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Scientific Fund of the Mayor of Vienna, European Society of Anaesthesiology
- Responsible party
- Principal investigator, David M Baron, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639780
- Sponsor's protocol ID
- 1043/2015
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2015
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Alterations of Stored Erythrocyte Membranes
- ClinicalTrials.gov ID
- NCT02639780
- Acronym / sponsor ID
- 1043/2015
- Conditions
- Coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Medical Scientific Fund of the Mayor of Vienna, European Society of Anaesthesiology
- Study start
- Dec 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- volunteers who will donate one unit of packed red blood cells
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- age below 18 years
- age above 60 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein expression pattern of packed red blood cellsthe proteome of packed red blood cells will be assessed at predefined time points | Other | healthy older female, healthy older male, healthy young female, healthy young male, obese older female, obese older male |
Primary outcome
protein expression pattern
Time frame: week 0
protein expression pattern
Time frame: week 2
protein expression pattern
Time frame: week 4
protein expression pattern
Time frame: week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
protein expression pattern (time frame: week 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.