Study of 'Vascular Competence' Profile and Endothelial Activation in the Hemolytic Uremic Syndrome in Children and Adults

NCT02904863 | Completed

• 2 other identifiers: 2012-032012-A00217-36
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The Hemolytic Uremic Syndrome (HUS) is a rare thrombotic microangiopathy (TMA), affecting both children and adults. HUS is characterized by the abnormal occurrence of diffuse thrombosis in the microcirculation resulting in the occurrence of ischemic events affecting especially the kidneys and is associated with hemolytic anemia. One of the major problems encountered in the management of HUS is the absence of reliable marker of treatment response or relapse; conventional hematological markers being too insensitive to judge therapeutic efficacy or identify early relapse. Data from the literature suggest that the endothelial cell is a major target of this syndrome. Our hypothesis is that an initial micro-endothelial activation plays a critical role in the initiation and / or relapse of the disease.The main objective of this study is to define a "vascular competence" profile in a population of patients with typical or atypical HUS; both in the acute phase and in remission of the disease.

Conditions

Hemolytic Uremic Syndrome

Outcome Measures

Primary Outcomes (2)

• number of circulating endothelial cells (CECs) and endothelial progenitor cells (EPCs)

  36 months

• number of endothelial progenitor cells (EPCs)

  36 months

Study Arms (1)

patients with HUS

EXPERIMENTAL

Biological: Extra blood draw samples

Interventions

Extra blood draw samples BIOLOGICAL

patients with HUS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a clinical diagnosis of typical or atypical HUS in acute phase

You may not qualify if:

• Patient with positive serological screening test for infection with the HIV.
• Patients with a history of cancer.
• Patients who have undergone organ transplantation or bone marrow.
• Patient with a vivid picture of autoimmune thrombotic thrombocytopenic purpura

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, France

Location

MeSH Terms

Conditions

Hemolytic-Uremic Syndrome

Condition Hierarchy (Ancestors)

Uremia; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia

Study Officials

• Urielle Desalbres

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 19, 2016
• Study Start: February 11, 2013
• Primary Completion: April 7, 2017
• Study Completion: July 27, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)