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OpenTrials
Completed

NCT Number: NCT05214300

Screening for Bleeding Disorders in Children

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Observe the correlation between the data of the interrogation

    Time frame: 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.

Other outcomes

  1. Test scores

    Time frame: day 1

    Test scores (HEMOSTOP, TOSETO ...) to propose a simple algorithm for carrying out screening assessments for congenital bleeding disorders in children.

  2. Compare several scores

    Time frame: day 1

    Compare several scores (HEMOSTOP, TOSETO ...) to propose a simple algorithm for carrying out screening assessments for congenital bleeding disorders in children.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2022
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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