R-FACT Study:Risk Factors for Alloimmunization After Red Blood Cell Transfusions
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
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 |
- 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) |
| Groups/Cohorts |
|---|
|
Cases and Controls
Cases: alloantibody formers Controls: non-alloantibody formers
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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| Contact: Jaap Jan Zwaginga, MD PhD | j.j.zwaginga@lumc.nl |
| Netherlands | |
| Leiden University Medical Center | Recruiting |
| Leiden, Netherlands, 2300RC | |
| Contact: Jaap Jan Zwaginga, MD Phd j.j.zwaginga@lumc.nl | |
| 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
Additional Information:
Publications:
| Responsible Party: | Sanquin Research & Blood Bank Divisions |
| ClinicalTrials.gov 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:
|
alloimmunization RBC clinicalfactors Risk |
ClinicalTrials.gov processed this record on May 19, 2013