Towards Improved Diagnostics for Suspected Platelet Function Disorders

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05985668

Enrollment

140

Registered

2023-08-14

Start date

2023-09-05

Completion date

2026-12-31

Last updated

2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platelet Disorder, Platelet Function Disorder, Thrombocytopathy

Keywords

diagnostic accuracy

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

12 Months to No maximum

Healthy volunteers

Yes

Inclusion criteria

, known defects: * 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

Exclusion criteria

, known defects:: * Antiplatelet or anticoagulant drugs * vWF:GPIb below 0.40 IU/mL * Hematocrit below 0.35 or above 0.50 * Other coagulation disorder Inclusion Criteria, suspected platelet function disorder: * Bleeding investigation at Karolinska University Hospital

Design outcomes

Primary

Measure	Time frame	Description
Platelet-thrombus formation on collagen surface	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.

Other

Measure	Time frame	Description
Platelet count effect on platelet-thrombus formation on collagen surface	At study inclusion	Whole-blood platelet-thrombus formation on collagen surface as for primary outcome. Subgroup analysis for patients with platelet count \< 150 x 10\^9 /L.
ddAVP effect on platelet-thrombus formation on collagen surface	Immediately before and 1 hour after administration of ddAVP.	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).
Thrombus formation on collagen/TF	At study inclusion	Thrombus formation on collagen surface/tissue-factor surface measured in a semi-automatic microchip flow chamber by a pressure sensor.

Countries

Sweden

Outcome results