FDA' s Advancing Regulatory Science: TRALI - Transfusion-Related Acute Lung Injury
Recommendation

3/4 February 2026
Evaluation, Implementation and Use of Suitable Technologies
End of March, scientists from the Food and Drug Administration, Silver Spring, Maryland, Acumen LLC, Burlingame, California, and Centers for Medicare & Medicaid Services, Baltimore, Maryland published their current data on Transfusion-Related Acute Lung Injury (TRALI) occurrence and risk factors among the U.S. elderly.
They claim to have collected data during 2007 through 2011 and show that Transfusion-related acute lung injury (TRALI) is a leading cause of transfusion-related deaths in the U.S. It occurs mostly within six hours of blood transfusion and the l eading hypothesis suggests the cause is substances released from activated neutrophils.
Following some of the findings:
- 2,556 TRALI diagnoses reported among 11,378,264 higher rate of blood transfusions among the inpatient transfusion stays for elderly Medicare beneficiaries: elderly 22.46/100,000 stays increased
- TRALI rates were higher for platelet- and plasma-containing transfusions
- TRALI rates increased by year of the study (2007-2011) and number of units
- Significantly higher odds of TRALI among specific groups
» persons 65 to 79 years vs. older than 79 years, with TRALI risk declining with advancing age
» females vs. males
» white versus nonwhite
» certain medical histories - post-inflammatory pulmonary fibrosis
- cancers of blood forming tissues
- pulmonary insufficiency following trauma or surgery
- tobacco use
- transfusion
Read more about the TRALI data direct in Advancing Regulatory Science.
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