Development a Rhesus Type Compatibility Test by Means of an Antibody Able to Recognize RH1 Antigen Grafted on a Biochip (ABORDAGE)

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Rh Incompatibility Reaction

Treatments: Other: Blood donation

Study type: Observational

Funder types: Other

Identifiers

NCT02857075

API/2013/38

Details and patient eligibility

About

Every year, several millions of red cell concentrates are transfused. For each of them, a pretransfusional compatibility test is performed. In France, an ABO compatibility test at the patient's bedside is performed, but rhesus compatibility is not yet checked. However, rhesus antigens are very immunogenic and could lead to Rh incompatibility or Rh disease.

The objective of ABORDAGE project is to develop another biochip that specifically captures RBCs according the presence of the RH1 antigen (also known as D antigen) at their surface.

Full description

Every year, several millions of red cell concentrates are transfused. For each of them, a pretransfusional compatibility test is performed. In France, an ABO compatibility test at the patient's bedside is performed, but rhesus compatibility is not yet checked. However, rhesus antigens are very immunogenic and could lead to Rh incompatibility or Rh disease. Rh incompatibility occurs when a woman with Rh-negative blood type is exposed to Rh-positive blood cells. This exposure leads to the sensitization of the women who develop anti-Rh immunoglobulin G (IgG). This immunization is one cause of the hemolytic disease of newborns (HDN). HDN results from an incompatibility between mother's blood and fetus' blood. It happens when fetal red blood cells (RBCs) present antigens inherited from the father but missing from the mother. Consequence of this incompatibility is the fetal RBCs destruction by mother's antibodies. Antibodies could be natural, like immunoglobulin M (IgM) anti-A or anti-B from the ABO system, or from an immunization. Rh incompatibility results from 2 main mechanisms. The first one is when a pregnancy Rh-negative woman is exposed to fetal Rh-positive RBCs. Rh incompatibility leads to anemia (mild to severe) or ultimately to the in utero death. The second occurs when Rh incompatible blood is transfused. This is the subject of this communication.

The investigators previously develop biochips and optical device to realize automatic ABO compatibility test at the patient's bedside (references to the Citation field). Based on this previously project, the goal of ABORDAGE project is to develop another biochip based on selective blood capture. The ABORDAGE chip has to specifically capture RBCs according the presence of the RH1 antigen (also known as D antigen) at their surface.

Enrollment: 45 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Donor inclusion criteria will be those of the Etablissement Français du Sang

Exclusion criteria

• Donor exclusion criteria will be those of the Etablissement Français du Sang

Trial design

45 participants in 2 patient groups

Rhesus positive individuals

Description:

Red cell concentrates from RH1 individuals from each ABO group is used for the study. Red cell concentrates derived from blood donation.

Treatment:

Other: Blood donation

Rhesus negative individuals

Description:

red cell concentrates from RH-1 individuals from each ABO group is used for the study. Red cell concentrates derived from blood donation.

Treatment:

Other: Blood donation