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ABSTRACT: Background
Combination 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 question
What is the bleeding complication risk associated with IET use in pleural infection?Study design and methods
This 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.Results
Overall, 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.Interpretation
IET 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.
SUBMITTER: Akulian J
PROVIDER: S-EPMC9773231 | biostudies-literature | 2022 Dec
REPOSITORIES: biostudies-literature

Akulian Jason J Bedawi Eihab O EO Abbas Hawazin H Argento Christine C Arnold David T DT Balwan Akshu A Batra Hitesh H Uribe Becerra Juan Pablo JP Belanger Adam A Berger Kristin K Burks Allen Cole AC Chang Jiwoon J Chrissian Ara A AA DiBardino David M DM Fuentes Xavier Fonseca XF Gesthalter Yaron B YB Gilbert Christopher R CR Glisinski Kristen K Godfrey Mark M Gorden Jed A JA Grosu Horiana H Gupta Mridul M Kheir Fayez F Ma Kevin C KC Majid Adnan A Maldonado Fabien F Maskell Nick A NA Mehta Hiren H Mercer Joshua J Mullon John J Nelson Darlene D Nguyen Elaine E Pickering Edward M EM Puchalski Jonathan J Reddy Chakravarthy C Revelo Alberto E AE Roller Lance L Sachdeva Ashutosh A Sanchez Trinidad T Sathyanarayan Priya P Semaan Roy R Senitko Michal M Shojaee Samira S Story Ryan R Thiboutot Jeffrey J Wahidi Momen M Wilshire Candice L CL Yu Diana D Zouk Aline A Rahman Najib M NM Yarmus Lonny L
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<h4>Background</h4>Combination 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.<h4>Research question</h4>What is the bleeding complication risk associated wi ...[more]