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

NCT01616329 | Completed

• 2 other identifiers: PPOC-08-006CCMO-NL29563.058.09
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemolysis

Keywords

alloimmunization; RBC; clinicalfactors; Risk

Outcome Measures

Primary Outcomes (1)

• Red blood cell allo-antibody formation

  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

  An average of 8 weeks after study initiation in a participating center

Study Arms (1)

Cases and Controls

Cases: alloantibody formers Controls: non-alloantibody formers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• children under 18 years
• patients with prior history of red blood cell transfusions and alloimmunization before study period

Sponsors & Collaborators

• Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research: lead
• Leiden University Medical Center: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, 2300RC, Netherlands

Location

Related Publications (5)

• Zalpuri S, Evers D, Zwaginga JJ, Schonewille H, de Vooght KM, le Cessie S, van der Bom JG. Immunosuppressants and alloimmunization against red blood cell transfusions. Transfusion. 2014 Aug;54(8):1981-7. doi: 10.1111/trf.12639. Epub 2014 Apr 1.

  PMID: 24689865 BACKGROUND

• Zalpuri S, Middelburg RA, Schonewille H, de Vooght KM, le Cessie S, van der Bom JG, Zwaginga JJ. Intensive red blood cell transfusions and risk of alloimmunization. Transfusion. 2014 Feb;54(2):278-84. doi: 10.1111/trf.12312. Epub 2013 Jun 19.

  PMID: 23782244 BACKGROUND

• Zalpuri S, Schonewille H, Middelburg R, van de Watering L, de Vooght K, Zimring J, van der Bom JG, Zwaginga JJ. Effect of storage of red blood cells on alloimmunization. Transfusion. 2013 Nov;53(11):2795-800. doi: 10.1111/trf.12156. Epub 2013 Mar 11.

  PMID: 23480520 BACKGROUND

• Zalpuri S, Zwaginga JJ, van der Bom JG. Risk Factors for Alloimmunisation after red blood Cell Transfusions (R-FACT): a case cohort study. BMJ Open. 2012 May 4;2(3):e001150. doi: 10.1136/bmjopen-2012-001150. Print 2012.

  PMID: 22561355 BACKGROUND

• Zalpuri S, Zwaginga JJ, le Cessie S, Elshuis J, Schonewille H, van der Bom JG. Red-blood-cell alloimmunization and number of red-blood-cell transfusions. Vox Sang. 2012 Feb;102(2):144-9. doi: 10.1111/j.1423-0410.2011.01517.x. Epub 2011 Jul 6.

  PMID: 21729098 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from consenting participants collected and retained: plasma,serum and buffy coat

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johanna van der Bom, MD Phd

  Sanquin- LUMC, Leiden

  PRINCIPAL INVESTIGATOR

• Jaap Jan Zwaginga, MD Phd

  Sanquin-Lumc, Leiden

  PRINCIPAL INVESTIGATOR

• Dorothea Evers, MD MSc

  LUMC Leiden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager CCTR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: June 11, 2012
• Study Start: January 1, 2009
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

NL (1)