Towards Improved Diagnostics for Suspected Platelet Function Disorders

Platelet Disorder Clinical Trial

Official title:

Towards Improved Diagnostics for Suspected Platelet Function Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985668
• Other study ID #: K-2023-0991
• Status: Recruiting
• Start date: September 5, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: Region Stockholm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months and older

Eligibility

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

Exclusion Criteria, suspected platelet function disorder::

• Antiplatelet or anticoagulant drugs
• vWF:GPIb below 0.40 IU/mL
• Hematocrit below 0.35 or above 0.50
• Other coagulation disorder

Related Conditions & MeSH terms

• Blood Platelet Disorders
• Platelet Disorder
• Thrombocytopathy

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	At study inclusion
Other	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).	Immediately before and 1 hour after administration of ddAVP.
Other	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.	At study inclusion
Primary	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.	At study inclusion