Completed

NCT Number: NCT02857075

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

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.

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Key information

Conditions

Rh Incompatibility Reaction

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood donation

Other

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.

Primary outcomes

Detection of presence or absence of red blood cell on biochips by measurement of optical absorption with a detection module.

Time frame: between 6 and 42 days after blood donation

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: ABORDAGE

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Aug 5, 2016
Registry last updated: Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.