Transfusion-Related Acute Lung Injury after Red Blood Cell, Plasma, and Platelet Administration 2013-2015

Project Title Transfusion-Related Acute Lung Injury after Red Blood Cell, Plasma, and Platelet Administration 2013-2015
Date Posted
Tuesday, September 10, 2019
Status
Complete
Deliverables
Description

Transfusion-related acute lung injury (TRALI) is an adverse event, broadly defined as the onset of respiratory distress during or within 6 hours of blood transfusion. TRALI is a leading cause of transfusion-associated fatalities reported to the U.S. Food and Drug Administration (FDA). In 2016, FDA expanded the data within Sentinel to include inpatient electronic medical record (EMR) data from HCA Healthcare (HCA). This assessment of TRALI after blood component exposure is the first Sentinel utilization of this new inpatient data source.

This project focused on data exploration and assessed the feasibility of utilizing Sentinel inpatient EMR data to capture exposure to blood components and TRALI. The objectives of the project were to: describe the occurrence of TRALI subsequent to blood component exposure and determine the positive predictive value (PPV) of an algorithm for identifying TRALI, as well as report transfused product exposure in identified TRALI cases. Exploratory analyses focused on feasibility of examining patient and TRALI associated transfusion risk factors, as well as identification of blood components, including component type and processing method (e.g., leukocyte-reduced, irradiated). Where possible, information was derived from medical chart review to inform these explorations.

The Sentinel Operations Center posted a final draft protocol for public comment from September 16, 2016, through September 30, 2016. The public comment period is now closed. No comments were received. 

Medical Product
blood transfusion
Health Outcome
tranfusion-related acute lung injury (TRALI)
Time Period
2013 - 2015
Assessment Type
Exploratory Analyses
Study Type
Protocol/Surveillance Plan
Workgroup Leader(s)

Protocol:

Meghan Baker MD, ScD; Candace Fuller PhD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Wendy Paul MD; Azadeh Shoaibi PhD, MHS; Craig Zinderman MD, MPH; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Final Report:

Meghan Baker MD, ScD; Candace Fuller PhD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Wendy Paul, MD; Azadeh Shoaibi PhD, MHS; Craig Zinderman MD, MPH; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Workgroup Members

Protocol:

Steven Anderson PhD, MPP; Howard Chazin MD, MBA; Pamela Clark MD, JD; Richard Forshee PhD; Mikhail Menis PharmD, MS; Manette Niu MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Carolyn Balsbaugh MPH; Fang Zhang PhD; Lauren Zichittella MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA 

Nicholas Bryant BBA; Jason Hickock MBA, RN; Karla Miller PharmD, BCPP; Caren Spencer-Smith MIS, MT(ASCP); HCA Healthcare, Nashville, TN 

Lesley Curtis PhD; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC

Stacey Honda MD; Kaiser Permanente, Hawaii, Honolulu, HI

Richard Kaufman MD; Brigham and Women's Hospital, Boston, MA; Harvard Medical School, Boston, MA 

Robert Rosofsky MA; Health Information Systems Consulting, Milton, MA

Jamie L. Todd MD; Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Duke University Medical Center, Durham, NC 

Final Report:

Steven Anderson PhD, MPP; Richard Forshee PhD; Mikhail Menis PharmD, MS; Manette Niu MD; Joyce Obidi, PhD; Wendy Paul, MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Austin Cosgrove; Margaret Johnson, MPH; Adee Kennedy, MPH; Mayura Shinde, PhD; Fang Zhang PhD; Lauren Zichittella MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA 

Jason Hickock MBA, RN; Karla M. Miller PharmD, BCPP; Russell Poland, PhD; Caren Spencer-Smith, MIS, MT(ASCP); Kimberly Smith, MBA; HCA Healthcare, Nashville, TN 

Stacey Honda MD; Kaiser Permanente, Hawaii, Honolulu, HI

Lesley Curtis PhD; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC

Richard Max Kaufman MD; Brigham and Women's Hospital, Boston, MA; Harvard Medical School, Boston, MA 

Robert Rosofsky MA; Health Information Systems Consulting, Milton, MA

Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CBER