Towards Improved Diagnostics for Suspected Platelet Function Disorders

December 1, 2023 updated by: Region Stockholm
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients recruited at Karolinska University Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At study inclusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At study inclusion
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).
Immediately before and 1 hour after administration of ddAVP.
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.
At study inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Collaborators

Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-2023-0991

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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