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R-FACT Study:Risk Factors for Alloimmunization After Red Blood Cell Transfusions (R-FACT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Sanquin Research & Blood Bank Divisions.
Recruitment status was  Recruiting
Leiden University Medical Center
Information provided by (Responsible Party):
Sanquin Research & Blood Bank Divisions Identifier:
First received: March 16, 2012
Last updated: June 7, 2012
Last verified: June 2012
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.

Alloimmunization to Transfused Red Blood Cell Antigens

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: R-FACT Study:Risk Factors for Alloimmunization After Red Blood Cell Transfusions

Resource links provided by NLM:

Further study details as provided by Sanquin Research & Blood Bank Divisions:

Primary Outcome Measures:
  • Red blood cell allo-antibody formation [ Time Frame: An average of 8 weeks after study initiation in a participating center ] [ Designated as safety issue: No ]
    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

Biospecimen Retention:   Samples With DNA
Blood samples from consenting participants collected and retained: plasma,serum and buffy coat

Estimated Enrollment: 1500
Study Start Date: January 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Cases and Controls
Cases: alloantibody formers Controls: non-alloantibody formers

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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 irregular red blood cell antibody formers, with no prior history of red blood cell transfusions and alloimmunization before the study period.

Controls will be all consecutive transfused patients who had received their first and subsequent red blood transfusions at the study center with no prior history of red blood cell transfusions and alloimmunization.


Inclusion Criteria:

  • First time ever Red blood cell transfusion recipients after the start of study period (January 2005)

Exclusion Criteria:

  • children under 18 years
  • patients with prior history of red blood cell transfusions and alloimmunization before study period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01616329

Contact: Jaap Jan Zwaginga, MD PhD

Leiden University Medical Center Recruiting
Leiden, Netherlands, 2300RC
Contact: Jaap Jan Zwaginga, MD Phd   
Sponsors and Collaborators
Sanquin Research & Blood Bank Divisions
Leiden University Medical Center
Principal Investigator: Johanna van der Bom, MD Phd Sanquin- LUMC, Leiden
Principal Investigator: Jaap Jan Zwaginga, MD Phd Sanquin-Lumc, Leiden
Principal Investigator: Saurabh Zalpuri, MD MSc Sanquin- LUMC, Leiden
  More Information

Responsible Party: Sanquin Research & Blood Bank Divisions Identifier: NCT01616329     History of Changes
Other Study ID Numbers: PPOC-08-006  CCMO-NL29563.058.09 
Study First Received: March 16, 2012
Last Updated: June 7, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Sanquin Research & Blood Bank Divisions:
Risk processed this record on February 11, 2016