Clinical trial NCT02857075: Development a Rhesus Type Compatibility Test by Means of an Antibody Able to Recognize RH1 Antigen Grafted on a Biochip
Official title: Enlargement of the SmarTTransfuser Biochip (ABO Compatibility) to the Detection of Rhesus (RH1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rh Incompatibility Reaction
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RH1 and RH-1 red cell concentrates, derived from blood donation, is used for this study

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of presence or absence of red blood cell on biochips by measurement of optical absorption with a detection module.
timeFrame: between 6 and 42 days after blood donation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHRU besancon
name: Bruno Wacogne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Charrière, K., A. Rouleau, O. Gaiffe, J. Fertey, P. Morel, V. Bourcier, C. Pieralli, W. Boireau, L. Pazart, and B. Wacogne. 2015. "Biochip Technology Applied to an Automated ABO Compatibility Test at the Patient Bedside." Sensors and Actuators B: Chemical 208 (March): 67-74. doi:10.1016/j.snb.2014.10.123.
citation: Charrière, Karine, Alain Rouleau, Olivier Gaiffe, Pascal Morel, Véronique Bourcier, Christian Pieralli, Wilfrid Boireau, Lionel Pazart, and Bruno Wacogne. 2015. "An Automated Medical Device for Ultimate ABO Compatibility Test at the Patient's Bedside - Towards the Automation of Point-of-Care Transfusion Safety:" In , 58-67. Lisbon, Portugal: SCITEPRESS - Science and and Technology Publications. doi:10.5220/0005248700580067.