Clinical Trial: R-FACT Study:Risk Factors for Alloimmunization After Red Blood Cell Transfusions

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: R-FACT Study:Risk Factors for Alloimmunization After Red Blood Cell Transfusions

Brief Summary: Alloantibodies can lead to serious clinical consequences and logistic problems like obtaining properly and timely matched blood for the patients who do develop these antibodies. Prevention of such serious events is possible by extended matching and typing of donor's blood against the patient's for all the possible antigens, but this process is cumbersome and costly. Identifying a high risk group will be a feasible first target for advanced matching a big step forward, and the aim of the investigators study. The aim of the project is to examine the association between clinical, environmental and genetic characteristics of the recipient of erythrocyte transfusions and the risk or resistance to immunization against erythrocyte alloantigens that he/she was exposed to during that transfusion episode.

Detailed Summary:

Introduction: Individuals exposed to red blood cell (RBC) alloantigens through transfusion, pregnancy, or transplantation may produce antibodies against the alloantigens expressed by RBCs. Although the incidence of these events is debated and ranges between percentages of 1-6% in single transfused patients and up to 30 % in poly-transfused patients (e.g. sickle cell disease, thalassemia and myelodysplasia), they can pose serious clinical problems such as delayed haemolytic reactions as well as logistic problems e.g. to obtain timely and properly matched transfusion blood for patients in which new alloantibodies are detected.

Rationale: It is known that the risk of a recipient to develop antibodies depends on dose and route of administration and the immunogenicity of the antigen, as well as on genetic or acquired patient-related factors. The latter factors however are ill defined and therefore we hypothesize that the particular clinical conditions (e.g. used medication, concomitant infection, cellular immunity) during which transfusions are given may contribute to the risk of immunization.

Research objective: Examine the association between clinical, environmental and genetic characteristics of the recipient of erythrocyte transfusions and the risk against immunization against erythrocyte alloantigens exposed to during that transfusion episode.

METHODOLOGY Study Design and study population We will perform a retrospective matched case- cohort study at hospitals nationwide from a period January 2005 to December 2011. Large red blood cell using hospitals will be selected as study bases. The study cohort will comprise of consecutive red blood cell transfused patients at the study center.

Cases are defined as first time ever irreg
Sponsor: Sanquin Research & Blood Bank Divisions

Current Primary Outcome: Red blood cell allo-antibody formation [ Time Frame: An average of 8 weeks after study initiation in a participating center ]

Outcome measure would be assessed in a participating study center after an average 8 weeks from the initiation of the study in that particular study center


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanquin Research & Blood Bank Divisions

Dates:
Date Received: March 16, 2012
Date Started: January 2009
Date Completion: August 2017
Last Updated: April 11, 2016
Last Verified: April 2016