Towards Improved Diagnostics for Suspected Platelet Function Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-05

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Platelet Function Disorder Platelet Disorder Thrombocytopathy

Keywords

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diagnostic accuracy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Suspected

Suspected Platelet Function Disorder during bleeding investigation

No interventions assigned to this group

Confirmed

Confirmed Platelet Function Disorder by Functional or Genetic Assay, or confirmed negative by gold standard assay

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Facility Contacts

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David Schmidt, MD, PhD

Role: primary

Other Identifiers

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K-2023-0991

Identifier Type: -

Identifier Source: org_study_id