Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05985668

Towards Improved Diagnostics for Suspected Platelet Function Disorders

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Platelet Function Disorder Blood Platelet Disorders Hematologic Diseases Hemic and Lymphatic Diseases Platelet Disorder Thrombocytopathy

Age range

12 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, Sweden

Location status: Recruiting

Location contact

David Schmidt, MD, PhD

CONTACT

[email protected]

0812370000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Platelet-thrombus formation on collagen surface

    Time frame: 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 outcomes

  1. Platelet count effect on platelet-thrombus formation on collagen surface

    Time frame: 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.

  2. ddAVP effect on platelet-thrombus formation on collagen surface

    Time frame: 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).

  3. Thrombus formation on collagen/TF

    Time frame: At study inclusion

    Thrombus formation on collagen surface/tissue-factor surface measured in a semi-automatic microchip flow chamber by a pressure sensor.

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.