Towards Improved Diagnostics for Suspected Platelet Function Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorRegion Stockholm
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Antiplatelet or anticoagulant drugs
vWF:GPIb below 0.40 IU/mL
Hematocrit below 0.35 or above 0.50
Other coagulation disorder
Trial population
Patients recruited at Karolinska University Hospital
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
140 Participants
are grouped into 2 trial groupsGroup A: Suspected
Group B: Confirmed
Trial outcomes
Primary outcomes
1
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.
Time frame
At study inclusionOther outcomes
1
Platelet count effect on platelet-thrombus formation on collagen surface
Whole-blood platelet-thrombus formation on collagen surface as for primary outcome. Subgroup analysis for patients with platelet count \< 150 x 10\^9 /L.
Time frame
At study inclusion2
ddAVP effect on platelet-thrombus formation on collagen surface
Whole-blood platelet-thrombus formation on collagen surface, similar as for primary outcome measurement. In a subset of patients with a clinical indication (physician discretion).
Time frame
Immediately before and 1 hour after administration of ddAVP.3
Thrombus formation on collagen/TF
Thrombus formation on collagen surface/tissue-factor surface measured in a semi-automatic microchip flow chamber by a pressure sensor.
Time frame
At study inclusionSponsors and contacts
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Region Stockholm
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov