Blood CoagulationNCT02594345
Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation
A study testing in vitro study in people with Blood Coagulation and Platelet Function, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
This study is designed to analyze the effect exosomes derived from red blood cell units have on blood coagulation and platelet function. It is an in vitro study using healthy volunteers' blood. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Coagulation, Platelet Function
- What is being tested?
- in vitro study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Dec 2015
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- pregnancy
- drug use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vitro Study of the Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation in Healthy Volunteers' Blood
This study is designed to analyze the effect exosomes derived from red blood cell units have on blood coagulation and platelet function. It is an in vitro study using healthy volunteers' blood.
Read the detailed description
The blood of 25 healthy volunteers will be exposed to exosomes derived from red blood cell units. The effects on coagulation and platelet function will be measured using thromboelastometry (ROTEM®) and FACS analysis.
- Conditions
- Blood Coagulation, Platelet Function
- Being tested
- in vitro study
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in vitro studyOther
Exosomes will be mixed with healthy volunteers' blood in vitro
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: in vitro study |
What is being measured
The primary outcome is the main question the study is designed to answer.
clotting time
measured by thromboelastometry (ROTEM® Analysis)
Measured: 2 months
Secondary outcomes (4)
clot formation
measured by thromboelastometry (ROTEM® Analysis)
Measured: 1h after exposure
clot stability
measured by thromboelastometry (ROTEM® Analysis)
Measured: 1h after exposure
clot lysis
measured by thromboelastometry (ROTEM® Analysis)
Measured: 1h after exposure
CD62P
FACS analysis
Measured: 3h after exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood CoagulationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Dania Fischer, Johann Wolfgang Goethe University Hospital
- Investigators
- Dania P Fischer, M.D., Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594345
- Sponsor's protocol ID
- ExoRBC
- Status last verified
- Feb 2016
- First submitted
- 30 Oct 2015
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Study of the Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation in Healthy Volunteers' Blood
- ClinicalTrials.gov ID
- NCT02594345
- Acronym / sponsor ID
- ExoRBC
- Conditions
- Blood Coagulation, Platelet Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Nov 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.
This study is designed to analyze the effect exosomes derived from red blood cell units have on blood coagulation and platelet function. It is an in vitro study using healthy volunteers' blood.
Detailed description
The blood of 25 healthy volunteers will be exposed to exosomes derived from red blood cell units. The effects on coagulation and platelet function will be measured using thromboelastometry (ROTEM®) and FACS analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: in vitro study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (2 listed)
- pregnancy
- drug use
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 |
|---|---|---|
| in vitro studyExosomes will be mixed with healthy volunteers' blood in vitro | Other | Intervention group |
Primary outcome
clotting time
Time frame: 2 months
measured by thromboelastometry (ROTEM® Analysis)
4 secondary outcomes
clot formation
Time frame: 1h after exposure
clot stability
Time frame: 1h after exposure
clot lysis
Time frame: 1h after exposure
CD62P
Time frame: 3h after exposure
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 23 Feb 2016.
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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.
Dania P Fischer, M.D. principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in vitro study in people with Blood Coagulation and Platelet Function, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 1 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 23 Feb 2016. 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 Germany. 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?
clotting time (time frame: 2 months). 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 23 Feb 2016.