NCT05214300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
Last Updated

January 28, 2022

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

December 24, 2021

Last Update Submit

January 17, 2022

Conditions

Bleeding Disorder

Keywords

von Willebrand diseasehemophilia A and Bother coagulant factor deficiencies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Test scores

    day 1

  • Compare several scores

    day 1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children 0-18 years old

You may qualify if:

  • 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.

You may not qualify if:

  • \- older than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Hemostatic Disordersvon Willebrand DiseasesHemophilia A

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersCoagulation Protein DisordersBlood Platelet DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Alexandre THERON

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2021

First Posted

January 28, 2022

Study Start

December 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 20, 2021

Last Updated

January 28, 2022

Record last verified: 2021-12

Locations

FR(1)