National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia.

NCT04070612 | Completed

• 1 other identifier: CHUBX 2005/18
• Study Type: observational
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France.

Conditions

Cytopenia; Autoimmune Haemolytic Anaemia; Thrombocytopenic Purpura, Immune

Keywords

Children

Outcome Measures

Primary Outcomes (10)

• Complete sustainable remission (yes/no) for children with autoimmune haemolytic anemias

  Absence of clinical signs of anemia (grade 0) And Hemoglobin \> 11 g / dl And reticulocytes \<120,000 / mm3 And haptoglobin\> 10 mg / dl And bilirubin \<10 mg / l or 17 μmol / l And no specific treatment for at least 12 months

  At the screening

• complete remission (yes/no) for children with autoimmune haemolytic anemias

  Absence of clinical signs of anemia (grade 0) And Hemoglobin\> 11 g / dl And reticulocytes \<120,000 / mm3 Regardless of the level of haptoglobin or bilirubin And specific treatment in progress or interrupted for less than 12 months

  At the screening

• partial remission (yes/no) for children with autoimmune haemolytic anemias

  Clinical Signs of Anemia (Grade 1 or 2) Or Hemoglobin from 7 to 11 g / dl Or reticulocytes\> 120,000 / mm3 Regardless of the level of haptoglobin or bilirubin

  At the screening

• no response (yes/no) for children with autoimmune haemolytic anemias

  Clinical Signs of Severe Anemia (Grade 3 or More) Or Hemoglobin \<7 g / dl

  At the screening

• deceased patient (yes/no) for children with autoimmune haemolytic anemias

  Death yes/no

  At the screening

• Complete sustainable remission (yes/no) for children with chronic immunologic thrombocytopenic purpura

  Absence of clinical signs of haemorrhage (grade 0) And platelets\> 100,000 / mm3 And no specific treatment for at least 12 months

  At the screening

• complete remission (yes/no) for children with chronic immunologic thrombocytopenic purpura

  Absence of clinical signs of haemorrhage (grade 0) And platelets\> 100,000 / mm3 And specific treatment in progress or interrupted for less than 12 months

  At the screening

• partial remission (yes/no) for children with chronic immunologic thrombocytopenic purpura

  Clinical Signs of Hemorrhage (Grade 1 or 2) Or platelets between 30,000 and 100,000 / mm3

  At the screening

• no response (yes/no) for children with chronic immunologic thrombocytopenic purpura

  Clinical Signs of Severe Hemorrhage (Grade 3 or Greater) Or Platelets \<30,000 / mm3

  At the screening

• deceased patient (yes/no) for children with chronic immunologic thrombocytopenic purpura

  Death yes/no

  At the screening

Study Arms (3)

children with autoimmune haemolytic anemia

A blood sample of 2 times 2 to 5 ml additional maximum

Other: Blood sample

Children with Evans syndrome

A blood sample of 2 times 2 to 5 ml additional maximum

Other: Blood sample

Children with Immune thrombocytopenic purpura

A blood sample of 2 times 2 to 5 ml additional maximum

Other: Blood sample

Interventions

Blood sample OTHER

A blood sample of 2 times 2 to 5 ml additional maximum

Children with Evans syndrome; Children with Immune thrombocytopenic purpura; children with autoimmune haemolytic anemia

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age strictly below 18 years of age at initial diagnosis
• Affiliate child or beneficiary of a social security scheme
• Child residing in metropolitan France
• Diagnosis of autoimmune haemolytic anemias, Evans syndrome and / or chronic Immune thrombocytopenic purpura
• Free, informed, written and signed consent

You may not qualify if:

• Diagnosis of constitutional haemolytic anemia
• Diagnosis of platelet constitutional disease

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

MeSH Terms

Conditions

Cytopenia; Anemia, Hemolytic, Autoimmune; Purpura, Thrombocytopenic, Idiopathic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hemolytic; Anemia; Autoimmune Diseases; Immune System Diseases; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Hemorrhagic Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yves PEREL, Pr

  Bordeaux University Hsopital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: April 4, 2007
• Primary Completion: June 8, 2012
• Study Completion: June 8, 2012
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share