Causes and Management of Children Presenting With Macrosc... | NCT07312461

Studies
Causes and Management of Children Presenting With Macroscopic Hematuria in the Pediatric Emergency Department

NCT07312461

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Dec 31, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Macroscopic Hematuria

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2024Actual

Primary Completion Date

Jan 2026Estimated

Completion Date

Jan 2026Estimated

First Submitted Date

Dec 10, 2025

First Submission Date that Met QC Criteria

Dec 30, 2025

First Posted Date

Dec 31, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2025

Last Update Posted Date

Dec 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Macroscopic hematuria. is a common symptom, leading to numerous emergency department visits in children of all ages.

It can be linked to many pathologies, and its management in the emergency department is not standardized.

Few articles describe the management of this symptom during pediatric emergency department visits.

Therefore, it is important to study this symptom and its management in order to establish a protocol.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Describe the different causes of this symptom		Up to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Minor subject (<18 years old)
Patient presenting to the pediatric emergency department with gross hematuria

Exclusion Criteria:

- Subject (and/or their parents) who expressed their opposition to participating in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

Minor subject (<18 years old) presenting to the pediatric emergency department with gross hematuria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ariane ZALOSZYC, MD	Contact	33 3 88 12 77 42		ariane.zaloszyc@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Pédiatrie 1 - Réanimation - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France