Platelet Function DisorderNCT05985668
Towards Improved Diagnostics for Suspected Platelet Function Disorders
An observational study of Platelet Function Disorder and Platelet Disorder, run by Region Stockholm at 1 site in Sweden.
Trial summary
This study aims to improve platelet function testing during bleeding investigations. To this end, the study will evaluate the diagnostic accuracy of novel platelet function tests in patients with confirmed or suspected platelet function disorders. Read more about this study
- Who is it for?
- Ages 12 months and olderHealthy volunteers can take part
- Conditions the study is for
- Platelet Function Disorder, Platelet Disorder, Thrombocytopathy
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- 5 Sep 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients recruited at Karolinska University Hospital
Who may be able to join
- Known platelet function disorder under follow-up at Karolinska University Hospital (genetic or functional assay)
- High likelihood of platelet function disorder (aberrant screening test with inheritance)
- Family investigation for platelet disorder
- Bleeding investigation at Karolinska University Hospital
Who cannot join
- Antiplatelet or anticoagulant drugs
- vWF:GPIb below 0.40 IU/mL
- Hematocrit below 0.35 or above 0.50
- Other coagulation disorder
- Antiplatelet or anticoagulant drugs
- vWF:GPIb below 0.40 IU/mL
- Hematocrit below 0.35 or above 0.50
- Other coagulation disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
David Schmidt, MD, PhD, 0812370000, david.schmidt@regionstockholm.se
About this study
This study aims to improve platelet function testing during bleeding investigations. To this end, the study will evaluate the diagnostic accuracy of novel platelet function tests in patients with confirmed or suspected platelet function disorders. Study participants will be recruited from patients that are referred to or treated at the Coagulation Unit, Karolinska University Hospital, and Pediatric Coagulation Unit, Astrid Lingren Children's Hospital.
- Keywords
- diagnostic accuracy
- Medical subject headings
- Blood Platelet Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspected | Suspected Platelet Function Disorder during bleeding investigation | |
| Confirmed | Confirmed Platelet Function Disorder by Functional or Genetic Assay, or confirmed negative by gold standard assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet-thrombus formation on collagen surface
Whole-blood platelet-thrombus formation on collagen surface measured in a semi-automatic microchip flow chamber by a pressure sensor. Coagulation activation is inhibited.
Measured: At study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start5 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Function DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985668
- Sponsor's protocol ID
- K-2023-0991
- Status last verified
- Jun 2023
- First submitted
- 30 Jun 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Improved Diagnostics for Suspected Platelet Function Disorders
- ClinicalTrials.gov ID
- NCT05985668
- Acronym / sponsor ID
- K-2023-0991
- Keywords
- diagnostic accuracy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Aug 2023 (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.
This study aims to improve platelet function testing during bleeding investigations. To this end, the study will evaluate the diagnostic accuracy of novel platelet function tests in patients with confirmed or suspected platelet function disorders. Study participants will be recruited from patients that are referred to or treated at the Coagulation Unit, Karolinska University Hospital, and Pediatric Coagulation Unit, Astrid Lingren Children's Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected | – | –Suspected Platelet Function Disorder during bleeding investigation |
| Confirmed | – | –Confirmed Platelet Function Disorder by Functional or Genetic Assay, or confirmed negative by gold standard assay |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients recruited at Karolinska University Hospital
Key inclusion criteria (4 listed)
- Known platelet function disorder under follow-up at Karolinska University Hospital (genetic or functional assay)
- High likelihood of platelet function disorder (aberrant screening test with inheritance)
- Family investigation for platelet disorder
- Bleeding investigation at Karolinska University Hospital
Key exclusion criteria (8 listed)
- Antiplatelet or anticoagulant drugs
- vWF:GPIb below 0.40 IU/mL
- Hematocrit below 0.35 or above 0.50
- Other coagulation disorder
- Antiplatelet or anticoagulant drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet-thrombus formation on collagen surface
Time frame: At study inclusion
Whole-blood platelet-thrombus formation on collagen surface measured in a semi-automatic microchip flow chamber by a pressure sensor. Coagulation activation is inhibited.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: Yes
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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.
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 Platelet Function Disorder and Platelet Disorder, run by Region Stockholm at 1 site in Sweden.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Dec 2023. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet-thrombus formation on collagen surface (time frame: At study inclusion). 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 Dec 2023.