NCT02857075

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

2.5 years

First QC Date

July 25, 2016

Last Update Submit

August 4, 2016

Conditions

Rh Incompatibility Reaction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

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.

Rhesus negative individualsRhesus positive individuals

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Interventions

Blood Donation

Intervention Hierarchy (Ancestors)

Tissue and Organ ProcurementHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Bruno Wacogne, PhD

    CHRU besancon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 5, 2016

Study Start

September 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 8, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share