Screening for Bleeding Disorders in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Bleeding Disorder

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 Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UHMontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children 0-18 years old

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test scores	Test scores (HEMOSTOP, TOSETO ...) to propose a simple algorithm for carrying out screening assessments for congenital bleeding disorders in children.	day 1
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Alexandre THERON, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: December 24, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: von Willebrand disease; hemophilia A and B; other coagulant factor deficiencies
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Hemorrhagic Disorders
• Other Study ID Numbers: RECHMPL21_0648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No