Pathophysiological Explorations of Red Blood Cells

Red Blood Cell Disorder Clinical Trial

— GR-Ex  

Official title:

Pathophysiological Explorations of Red Blood Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03541525
• Other study ID #: IMNIS2015-04
• Status: Recruiting
• Start date: October 16, 2017
• Est. completion date: October 15, 2037

Study information

• Verified date: July 2023
• Source: Imagine Institute
• Contact: Sandra Manceau, PhD
• Phone: +33171196435
• Email: sandra.manceau[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

GR-Ex is a program labelled by Labex (Laboratory of Excellence) by the French Ministry of Higher Education and Research. This program aims to develop the means to improve knowledge in the physiology and pathologies of erythropoiesis, red blood cells and iron metabolism, and to develop new therapeutic protocols capable of providing added value in terms of innovation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3750
• Est. completion date: October 15, 2037
• Est. primary completion date: October 15, 2037
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• To be affected or have a family history of disease bound to the red blood cell,
• For adult subjects, have signed an informed consent form,
• For minor or major under legal safeguard subjects, the form must be signed by both parents (for minors) or by the legal representative,
• Be affiliated to health insurance.

Exclusion Criteria:

• Being deprived of freedom

Related Conditions & MeSH terms

• Red Blood Cell Disorder

Intervention

Other:
• Biological sampling
Biological samples including blood, surgical remainder, urine,...

Locations

Country	Name	City	State
France	Hopital Necker - Enfants malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Imagine Institute

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Innovative markers of spleen fonctionality	Retention rate (%) of red blood cells using Microsphiltration compared with non affected subjects	20 years
Primary	Quantification of inflammation in sickle cell disease	Activation rate of circulating mastocytes (%)	20 years
Primary	Markers of post-artesunate hemolysis	Concentration of pitted red blood cells at day 3	20 years
Primary	Correlation between transfusion yield and the storage of red blood cell bags	Increasing in haemoglobin concentration at 6 hours post transfusion	20 years
Primary	Efficiency of Phosphodiesterase inhibitor on neutrophil adhesion in Sickle cell disease	Proportional change in adhesion rate (%) of neutrophils measured in the peripheral blood before and after treatment with phosphodiesterase inhibitors	20 years
Primary	Quantification of mitochondria removal during erythropoiesis in SDC patients, consequences on the mature RBC	Mitochondria rate and level of ROS in RBC measured by Flow Cytometry	20 years
Primary	Study of iron metabolism in Diamond-Blackfan Anemia patients	Dosage of iron metabolism parameters	20 years