Rh Incompatibility ReactionABORDAGENCT02857075
Development a Rhesus Type Compatibility Test by Means of an Antibody Able to Recognize RH1 Antigen Grafted on a Biochip
An observational study of Rh Incompatibility Reaction, run by Centre Hospitalier Universitaire de Besancon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rh Incompatibility Reaction
- What is being tested?
- Blood donation
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: RH1 and RH-1 red cell concentrates, derived from blood donation, is used for this study
Who may be able to join
- Donor inclusion criteria will be those of the Etablissement Français du Sang
Who cannot join
- Donor exclusion criteria will be those of the Etablissement Français du Sang
About this study
Official title: 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.
Read the 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.
- Conditions
- Rh Incompatibility Reaction
- Being tested
- Blood donation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood donationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood donation | |
| 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. Receives: Other: Blood donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between 6 and 42 days after blood donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startSep 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rh Incompatibility ReactionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Wacogne, PhD, Principal investigator, CHRU besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857075
- Sponsor's protocol ID
- API/2013/38
- Acronym
- ABORDAGE
- Status last verified
- Aug 2016
- First submitted
- 25 Jul 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enlargement of the SmarTTransfuser Biochip (ABO Compatibility) to the Detection of Rhesus (RH1)
- ClinicalTrials.gov ID
- NCT02857075
- Acronym / sponsor ID
- ABORDAGE / API/2013/38
- Conditions
- Rh Incompatibility Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhesus positive individuals | – | Other: Blood donationRed cell concentrates from RH1 individuals from each ABO group is used for the study. Red cell concentrates derived from blood donation. |
| Rhesus negative individuals | – | Other: Blood donationred cell concentrates from RH-1 individuals from each ABO group is used for the study. Red cell concentrates derived from blood donation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- RH1 and RH-1 red cell concentrates, derived from blood donation, is used for this study
Key inclusion criteria (1 listed)
- Donor inclusion criteria will be those of the Etablissement Français du Sang
Key exclusion criteria (1 listed)
- Donor exclusion criteria will be those of the Etablissement Français du Sang
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood donationRed 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. | Other | Rhesus negative individuals, Rhesus positive individuals |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- BackgroundCharrière, 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.
- BackgroundCharrière, 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Wacogne, PhD principal investigator
CHRU besancon
Questions about this trial
What is this clinical trial studying?
An observational study of Rh Incompatibility Reaction, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02857075, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.