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Multicenter Study Observational Study
Bleeding risk with combination intrapleural fibrinolytic and enzyme therapy in pleural infection - an international, multicenter, retrospective cohort study.
- Jason Akulian, Eihab O Bedawi, Hawazin Abbas, Christine Argento, David T Arnold, Akshu Balwan, Hitesh Batra, Juan Pablo Uribe Becerra, Adam Belanger, Kristin Berger, Allen Cole Burks, Jiwoon Chang, Ara A Chrissian, David M DiBardino, Xavier Fonseca Fuentes, Yaron B Gesthalter, Christopher R Gilbert, Kristen Glisinski, Mark Godfrey, Jed A Gorden, Horiana Grosu, Mridul Gupta, Fayez Kheir, Kevin C Ma, Adnan Majid, Fabien Maldonado, Nick A Maskell, Hiren Mehta, Joshua Mercer, John Mullon, Darlene Nelson, Elaine Nguyen, Edward M Pickering, Jonathan Puchalski, Chakravarthy Reddy, Alberto E Revelo, Lance Roller, Ashutosh Sachdeva, Trinidad Sanchez, Priya Sathyanarayan, Roy Semaan, Michal Senitko, Samira Shojaee, Ryan Story, Jeffrey Thiboutot, Momen Wahidi, Candice L Wilshire, Diana Yu, Aline Zouk, Najib M Rahman, Lonny Yarmus, and Interventional Pulmonary Outcomes Group.
- Division of Pulmonary and Critical Care, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC; Carolina Center for Pleural Diseases, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.
- Chest. 2022 Dec 1; 162 (6): 138413921384-1392.
BackgroundCombination intrapleural fibrinolytic and enzyme therapy (IET) has been established as a therapeutic option in pleural infection. Despite demonstrated efficacy, studies specifically designed and adequately powered to address complications are sparse. The safety profile, the effects of concurrent therapeutic anticoagulation, and the nature and extent of nonbleeding complications remain poorly defined.Research QuestionWhat is the bleeding complication risk associated with IET use in pleural infection?Study Design And MethodsThis was a multicenter, retrospective observational study conducted in 24 centers across the United States and the United Kingdom. Protocolized data collection for 1,851 patients treated with at least one dose of combination IET for pleural infection between January 2012 and May 2019 was undertaken. The primary outcome was the overall incidence of pleural bleeding defined using pre hoc criteria.ResultsOverall, pleural bleeding occurred in 76 of 1,833 patients (4.1%; 95% CI, 3.0%-5.0%). Using a half-dose regimen (tissue plasminogen activator, 5 mg) did not change this risk significantly (6/172 [3.5%]; P = .68). Therapeutic anticoagulation alongside IET was associated with increased bleeding rates (19/197 [9.6%]) compared with temporarily withholding anticoagulation before administration of IET (3/118 [2.6%]; P = .017). As well as systemic anticoagulation, increasing RAPID score, elevated serum urea, and platelets of < 100 × 109/L were associated with a significant increase in bleeding risk. However, only RAPID score and use of systemic anticoagulation were independently predictive. Apart from pain, non-bleeding complications were rare.InterpretationIET use in pleural infection confers a low overall bleeding risk. Increased rates of pleural bleeding are associated with concurrent use of anticoagulation but can be mitigated by withholding anticoagulation before IET. Concomitant administration of IET and therapeutic anticoagulation should be avoided. Parameters related to higher IET-related bleeding have been identified that may lead to altered risk thresholds for treatment.Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.
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