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Recruiting NCT07302087

Platelet Serotonin Deficiencies: the Strasbourg Experience

Observational Hemorrhagic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hemorrhagic Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Hemorrhagic syndromes are investigated using algorithms established by reference centers and hemostasis societies. The investigation of platelet dense granules (nucleotide and serotonin testing) is part of the second-line tests. It can be performed in cases of platelet aggregation abnormalities in platelet-rich plasma (PRP) suggesting a secretion abnormality, or in cases where the latter is normal, it can be performed if the patient's clinical presentation points to a primary hemostasis abnormality and the clinician wishes to pursue further investigations Intraplatelet serotonin deficiencies are often iatrogenic and may be accompanied by bleeding. Their impact on platelet function is poorly documented.

Primary outcome measures

  • Score of ISTH BAT Hemorrhagic Questionnaire [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

  • Adult patient (≥ 18 years old)
  • Treated at Strasbourg University Hospital for a hemorrhagic syndrome, suggesting a primary hemostasis abnormality and normal von Willebrand factor, during the period from January 1, 2023, to April 1, 2024.

Exclusion criteria

\- Refusal to participate in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Centre de Ressources et de Compétences des Maladies Hémorragiques Constitutionnelles - CHU — Strasbourg

Identifiers

NCT: NCT07302087 · 9484

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗