Screening for Bleeding Disorders in Children

Completed

• Conditions: Bleeding Disorder

• Registration Number: NCT05214300
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-12-01
• Status Verified: 2021-12
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-20
• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2022-01-17
• Last Update Submitted: 2022-01-17
• Study First Posted: 2022-01-28
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Observe the correlation between the data of the interrogation	1 day	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.

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France