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

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Details

Basic Details

Date Posted:

Monday, September 9, 2019

Status:

Complete

Medical Product:

blood transfusion

Health Outcome(s):

transfusion-related acute lung injury (TRALI)

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.

Deliverables (3)

Additional Information

Additional Details

FDA Center:

CBER

Time Period:

2013 - 2015

Study Type:

Protocol/Surveillance Plan

Assessment Type:

Exploratory Analyses

HOI Study Type:

Validations Supported by Traditional Medical Chart Review

Data Sources:

Sentinel Distributed Database (SDD)

Contributors

Workgroup Leader(s):

Protocol:

Meghan Baker, MD, ScD; Candace Fulle,r 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

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

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