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

Enlargement of the SmarTTransfuser Biochip (ABO Compatibility) to the Detection of Rhesus (RH1)

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.

Study Overview

• Status: Completed
• Conditions: Rh Incompatibility Reaction
• Intervention / Treatment: Other: Blood donation

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.

• Study Type: Observational
• Enrollment (Actual): 45

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

RH1 and RH-1 red cell concentrates, derived from blood donation, is used for this study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rhesus positive individuals; Red cell concentrates from RH1 individuals from each ABO group is used for the study. Red cell concentrates derived from blood donation.	Other: Blood donation; Red cell concentrates derived from healthy blood donating people. In France, all blood donation is realized by the Etablissement Français du Sang, so all the study samples are from this center.
Rhesus negative individuals; red cell concentrates from RH-1 individuals from each ABO group is used for the study. Red cell concentrates derived from blood donation.	Other: Blood donation; Red cell concentrates derived from healthy blood donating people. In France, all blood donation is realized by the Etablissement Français du Sang, so all the study samples are from this center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of presence or absence of red blood cell on biochips by measurement of optical absorption with a detection module.	Detection of red blood cell capture relies on optical absorption. Electroluminescent diodes will illuminate the surfaces of biochips and photoreceptors placed opposite will detect the amount of light which crosses the surfaces. First, a reference value is taken. Then, blood is injected on the surface and rinsed, to remove unbound ligands. If red blood cells have been trapped, light is absorbed. If not, no absorption is observe. Absorbance level are collected and correlation between the percentage of red cells on surfaces and absorbance are analysed.	between 6 and 42 days after blood donation

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Bruno Wacogne, PhD, CHRU Besançon

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Estimate): August 8, 2016
• Last Update Submitted That Met QC Criteria: August 4, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: API/2013/38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO