What is the single type of blood product most frequently implicated in fatal cases of Transfusion-Related Acute Lung Injury (TRALI) reported to the Food and Drug Administration (FDA)?

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Blood Product Most Frequently Implicated in Fatal TRALI Cases Reported to FDA Prior to 2007

Fresh frozen plasma (FFP) is the single type of blood product most frequently implicated in fatal cases of transfusion-related acute lung injury (TRALI) reported to the FDA prior to 2007.

Evidence Supporting FFP as Primary Culprit in Fatal TRALI

The evidence clearly identifies FFP as the most common blood product associated with fatal TRALI cases:

  • A retrospective review of fatalities caused by TRALI over a 5-year period (1997-2002) reported to the Center for Biologics Evaluation and Research found that FFP was implicated in one-half of all fatal TRALI cases, while red blood cells were involved in approximately one-third of cases 1.

  • FFP and platelet concentrates are consistently identified as the most frequently implicated blood products in TRALI 2, 3. Among these, FFP has been documented as having the highest association with fatal outcomes.

  • The European guidelines on management of bleeding following major trauma specifically note that "FFP and platelet concentrates appear to be the most frequently implicated blood products in transfusion-related acute lung injury" 2.

Pathophysiology of FFP-Associated TRALI

The higher incidence of TRALI with FFP can be explained by several factors:

  • FFP contains higher concentrations of donor antibodies compared to other blood products. These antibodies (particularly anti-HLA and anti-neutrophil antibodies) are primary mediators in the pathogenesis of TRALI 4.

  • Female donors with previous pregnancies frequently have HLA antibodies (overall prevalence of 24%), with increasing prevalence related to the number of previous pregnancies 4. Historically, a significant portion of FFP came from female donors.

  • The "two-hit" mechanism of TRALI involves:

    1. A predisposing inflammatory condition in the recipient
    2. The passive transfer of neutrophil or HLA antibodies from the donor plasma 5

Epidemiology and Risk Reduction

  • The frequency of reported TRALI/possible TRALI cases has been documented as 1:22,500 for FFP compared to 1:82,000 for red blood cells 6, highlighting the significantly higher risk associated with FFP.

  • Recognition of the role of anti-leukocyte antibodies has led to new strategies to reduce TRALI risk, including policies to produce plasma components primarily from male donors 4, 3.

  • Implementation of male-only plasma policies has shown a positive impact on reducing TRALI incidence 6.

Clinical Presentation and Management

TRALI typically presents with:

  • Acute respiratory distress
  • Hypoxemia
  • Non-cardiac pulmonary edema within 6 hours of transfusion
  • Bilateral pulmonary infiltrates on chest imaging

The fatality rate of TRALI has been reported to be 5-25%, making it one of the leading causes of transfusion-related mortality 7, 4.

Answer to Multiple Choice Question

Based on the evidence presented, the correct answer is: A. Fresh, frozen plasma

This conclusion is supported by multiple studies and guidelines that consistently identify FFP as the blood product most frequently implicated in fatal TRALI cases reported to the FDA prior to 2007.

References

Research

Fatalities caused by TRALI.

Transfusion medicine reviews, 2004

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Transfusion-Associated Risks in Patients with Ascites and Pleural Effusions

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Transfusion Related Acute Lung Injury (TRALI): A Single Institution Experience of 15 Years.

Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion, 2016

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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