- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07302087
Platelet Serotonin Deficiencies: the Strasbourg Experience (SEROTSTG)
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
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dominique Desprez, MD
- Phone Number: 33 3 88 12 83 71
- Email: dominique.desprez@chru-strasbourg.fr
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:
- Dominique Desprez, MD
- Phone Number: 33 3 88 12 83 71
- Email: dominique.desprez@chru-strasbourg.fr
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Sub-Investigator:
- AMANDINE ROBERT, MD
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Principal Investigator:
- LAURENT SATTLER, MD
-
Sub-Investigator:
- OLIVIER FEUGEAS, MD
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Sub-Investigator:
- ARNAUD DUPUIS, MD
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Sub-Investigator:
- DIHIA CHEBBAH, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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