Platelet Dysfunction in Blood DonorsDysPlaqNCT03599219
Platelet Dysfunction in Blood Donors
A study testing sample in people with Platelet Dysfunction in Blood Donors, run by Etablissement Français du Sang at 1 site in France.
Trial summary
Platelets are circulating blood cells. They bind to each other and to the damaged vessel wall to prevent excessive bllod loss. Unlike quantitative platelet defects, there is no automated, simple test to diagnose qualitative platelets defects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet Dysfunction in Blood Donors
- What is being tested?
- sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2017to 7 Jun 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any male or female volunteer eligible for the blood donation
Who cannot join
- Subject with contraindications to blood donation:
- weight <50 kg;
- severe fatigue,
- anemia,
- insulin-dependent diabetes;
- subject treated for epileptic seizures or having followed a treatment whose arrest is less than 14 days old.
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- active pregnancy or childbirth less than 6 months old.
- viral disease (eg influenza, gastroenteritis ...) active less than two weeks after the end of symptoms.
- waiting period not respected after certain acts of daily life according to the regulatory criteria set by the EFS
- HIV infection, hepatitis B, hepatitis C
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Platelet Dysfunction Inblood With a Bleeding History
Platelets are circulating blood cells. They bind to each other and to the damaged vessel wall to prevent excessive bllod loss. Unlike quantitative platelet defects, there is no automated, simple test to diagnose qualitative platelets defects. However, these defects expose to bleeding in a surgical situation and could explain the transfusion inefficiency of some platelet concentrates.
In recent decades, considerable progress has been made in understanding qualitative platelet disorders.
In this project, we propose to submit blood donors to a standardized hemorrhagic diathesis questionnaire and to compare the prevalence of platelet function abnormalities in blood donors with and without hemorrhagic diathesis.
Read the detailed description
Primary objective specify the prevalence of qualitative platelet disorders in blood donors with i) a clinical history of bleeding diathesis collected through a standardized and validated questionnaire ii) and / or a hematoma (more than 4 cm) that occurred during blood donation.
Secondary objectives to obtain the prevalence of other defects of hemostasis
- Conditions
- Platelet Dysfunction in Blood Donors
- Being tested
- sample
- Keywords
- platelets, bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sampleBiological
Also called questionnary to obtain an hemorrhagic score
confirmation of platelet dysfunction
| Study group | Role | What they receive |
|---|---|---|
| case | Other | donors with an hemorrhagic score >2 and / or hematoma (more than 4 cm) that occurred during blood donation Receives: Biological: sample |
| control | Other | donors with an hemorrhagic score <2. Receives: Biological: sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet functions
Quantification of surface platelet proteins by flow cytometry
Measured: first visit 1 week
Secondary outcomes (1)
Exploration of Coagulation
Von Willebrand factor quantification
Measured: first visit 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start10 Jul 2017
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Dysfunction in Blood DonorsStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective case control
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Etablissement Français du Sang
- Sponsor type
- University, hospital or other
- Collaborators
- University of Marseille
- Responsible party
- Sponsor
- Investigators
- Picard Christophe, Dr, Principal investigator, Etablissement francais du sang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599219
- Sponsor's protocol ID
- APR2016-27
- Other IDs
- 2016-A00117-44
- Acronym
- DysPlaq
- Status last verified
- Jan 2024
- First submitted
- 27 Feb 2018
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Platelet Dysfunction Inblood With a Bleeding History
- ClinicalTrials.gov ID
- NCT03599219
- Acronym / sponsor ID
- DysPlaq / APR2016-27
- Conditions
- Platelet Dysfunction in Blood Donors
- Keywords
- platelets, bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Etablissement Français du SangUniversity, hospital or other
- Collaborators
- University of Marseille
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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.
Platelets are circulating blood cells. They bind to each other and to the damaged vessel wall to prevent excessive bllod loss. Unlike quantitative platelet defects, there is no automated, simple test to diagnose qualitative platelets defects. However, these defects expose to bleeding in a surgical situation and could explain the transfusion inefficiency of some platelet concentrates.
In recent decades, considerable progress has been made in understanding qualitative platelet disorders.
In this project, we propose to submit blood donors to a standardized hemorrhagic diathesis questionnaire and to compare the prevalence of platelet function abnormalities in blood donors with and without hemorrhagic diathesis.
Detailed description
Primary objective specify the prevalence of qualitative platelet disorders in blood donors with i) a clinical history of bleeding diathesis collected through a standardized and validated questionnaire ii) and / or a hematoma (more than 4 cm) that occurred during blood donation.
Secondary objectives to obtain the prevalence of other defects of hemostasis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective case control
| Arm | Type | Receives |
|---|---|---|
| case | Other | Biological: sampledonors with an hemorrhagic score >2 and / or hematoma (more than 4 cm) that occurred during blood donation |
| control | Other | Biological: sampledonors with an hemorrhagic score <2. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any male or female volunteer eligible for the blood donation
Key exclusion criteria (10 listed)
- Subject with contraindications to blood donation:
- weight <50 kg;
- severe fatigue,
- anemia,
- insulin-dependent diabetes;
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 |
|---|---|---|
| sampleAlso: questionnary to obtain an hemorrhagic scoreconfirmation of platelet dysfunction | Biological | case, control |
Primary outcome
Platelet functions
Time frame: first visit 1 week
Quantification of surface platelet proteins by flow cytometry
1 secondary outcome
Exploration of Coagulation
Time frame: first visit 1 week
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 31 Jan 2024.
- Individual participant dataSharing planned: Undecided
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.
Picard Christophe, Dr principal investigator
Etablissement francais du sang
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sample in people with Platelet Dysfunction in Blood Donors, run by Etablissement Français du Sang at 1 site in France.
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 10 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 31 Jan 2024. 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 France. 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?
Platelet functions (time frame: first visit 1 week). 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 31 Jan 2024.