Platelet Serotonin Deficiencies: the Strasbourg Experience (SEROTSTG)

December 11, 2025 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Contact

Study Locations

      • Strasbourg, France, 67091
        • Recruiting
        • Centre de Ressources et de Compétences des Maladies Hémorragiques Constitutionnelles - CHU de Strasbourg - France
        • Principal Investigator:
          • Dominique DESPREZ, MD
        • Contact:
        • Sub-Investigator:
          • AMANDINE ROBERT, MD
        • Principal Investigator:
          • LAURENT SATTLER, MD
        • Sub-Investigator:
          • OLIVIER FEUGEAS, MD
        • Sub-Investigator:
          • ARNAUD DUPUIS, MD
        • Sub-Investigator:
          • DIHIA CHEBBAH, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of ISTH BAT Hemorrhagic Questionnaire
Time Frame: Up to 12 months

ISTH BAT bleeding questionnaire with its 12-item grid scored from 0 to 4:

A score ≥ 4 in men or ≥ 6 in women makes the presence of a constitutional hemostasis disorder highly probable

Up to 12 months

Collaborators and Investigators

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

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)

November 25, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 9484

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.

Clinical Trials on Hemorrhagic Syndrome

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