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
Thursday, September 15, 2016
Status
Complete
Deliverables
Description

This protocol examines the feasibility of utilizing Hospital Corporation of America’s (HCA) Sentinel database to capture exposure to blood components and the outcome of transfusion-related acute lung injury (TRALI). The assessment will also describe incidence rates of TRALI subsequent to blood component exposure.

The Sentinel Operations Center posted this final draft protocol for public comment from September 16, 2016, through September 30, 2016. The public comment period is now closed. Any revisions done to this protocol after it has been posted for public comment will be noted in the change log document included in the amended protocol. Posting of the revised document will be listed on the Sentinel homepage, on the relevant assessments project details page, and in the Sentinel RSS feed.

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

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 Zimmerman MD, MPH; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Workgroup Members

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; Stacey Honda MD; Karla Miller PharmD, BCPP; Caren Spencer-Smith MI; Hospital Corporation of America, Nashville, TN 

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

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 

Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CBER