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

Recommendation

10/11 November 2020

Live Online Conference - Quality, Safety and GMP for Advanced Therapy Medicinal Products (ATMPs)

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.