Towards Improved Diagnostics for Suspected Platelet Function Disorders

NCT05985668 | Recruiting

• 1 other identifier: K-2023-0991
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Function Disorder; Platelet Disorder; Thrombocytopathy

Keywords

diagnostic accuracy

Outcome Measures

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.

  At study inclusion

Other Outcomes (3)

• Platelet count effect on platelet-thrombus formation on collagen surface

  At study inclusion

• ddAVP effect on platelet-thrombus formation on collagen surface

  Immediately before and 1 hour after administration of ddAVP.

• Thrombus formation on collagen/TF

  At study inclusion

Study Arms (2)

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

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients recruited at Karolinska University Hospital

You may qualify if:

• 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

You may not qualify if:

• Antiplatelet or anticoagulant drugs
• vWF:GPIb below 0.40 IU/mL
• Hematocrit below 0.35 or above 0.50
• Other coagulation disorder
• Bleeding investigation at Karolinska University Hospital
• Antiplatelet or anticoagulant drugs
• vWF:GPIb below 0.40 IU/mL
• Hematocrit below 0.35 or above 0.50
• Other coagulation disorder

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Blood Platelet Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: August 14, 2023
• Study Start: September 5, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)