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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05214300
Other study ID # RECHMPL21_0648
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date December 20, 2021

Study information

Verified date December 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators try to improve the screening of bleeding disorders in children by identifying symptoms, laboratory abnormalities and clinical scores discriminating patients congenital bleeding disorders in order to create a simple screening algorithm applicable in pediatrics, aiming for use in pre-anesthetic consultation and in consultation by pediatricians and general practitioners.


Description:

Objective : To determine simple clinical and biological factors that can improve the screening of hemostatic diseases at risk of hemorrhage in children. Method: - Retrospective inclusion of all patients <18 years referred to the CRTH in pediatric consultation for the reason of exploration of a hemorrhagic syndrome or exploration of an anomaly in the hemostasis assessment. - Data collected (by collection in the medical file): Patient data: Age, sex, personal and family history of hemorrhagic disease Clinical data: hemorrhagic symptomatology (epistaxis, gingivorrhagia, etc.) Biological data: PT, TCK, factor assay, platelet function Medical data: complete diagnosis if diagnosis of hemorrhagic disease - Scores: HEMOSTOP, PBQ, ISTH, TOSETTO score - Analyzes: calculation of the Odd Ratio, AUC, Se, Sp, VPP, VPN for different clinical / biological factors and each score.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date December 20, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion criteria: - referred by their general practitioner or another caring physician for evaluation of bleeding symptoms - abnormal laboratory test results or family study - the patient being the first-degree relative of a patient with a known bleeding disorder. Exclusion criteria: - older than 18 years old.

Study Design


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Test scores Test scores (HEMOSTOP, TOSETO ...) to propose a simple algorithm for carrying out screening assessments for congenital bleeding disorders in children. day 1
Other Compare several scores Compare several scores (HEMOSTOP, TOSETO ...) to propose a simple algorithm for carrying out screening assessments for congenital bleeding disorders in children. day 1
Primary Observe the correlation between the data of the interrogation Observe the correlation between the data of the interrogation, the clinical examination and the clinical history and the demonstration of a confirm congenital bleeding disorder. 1 day
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