Screening for Bleeding Disorders in Children

Bleeding Disorder Clinical Trial

Official title:

Screening for Bleeding Disorders in Children: Evaluation of the Elements of the Interrogation, the Screening Workup and the Clinical Scores

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214300
• Other study ID #: RECHMPL21_0648
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Bleeding Disorder
• Blood Coagulation Disorders
• Hemorrhage
• Hemorrhagic Disorders
• Hemostatic Disorders

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