• Login
    View Item 
    •   UMB Digital Archive
    • UMB Open Access Articles
    • UMB Open Access Articles 2019
    • View Item
    •   UMB Digital Archive
    • UMB Open Access Articles
    • UMB Open Access Articles 2019
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of UMB Digital ArchiveCommunitiesPublication DateAuthorsTitlesSubjectsThis CollectionPublication DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    Statistics

    Display statistics

    Prophylactic epinephrine for the prevention of transbronchial lung biopsy-related bleeding in lung transplant recipients (PROPHET) study: A protocol for a multicentre randomised, double-blind, placebo-controlled trial

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Author
    Kalchiem-Dekel, O.
    Iacono, A.
    Pickering, E.M.
    Date
    2019
    Journal
    BMJ Open
    Publisher
    BMJ Publishing Group
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1136/bmjopen-2018-024521
    Abstract
    Introduction Transbronchial lung biopsy (TBLB) is frequently performed in single-lung and double-lung transplant recipients for evaluation of clinical and radiological findings as well as routine surveillance for acute cellular rejection. While rates of clinically significant TBLB-related haemorrhage are <1% for all comers, the incidence in lung transplant recipients is reported to be higher, presumably due to persistent allograft inflammation and alterations in allograft blood flow. While routinely performed by some bronchoscopists, the efficacy and safety profile of prophylactic administration of topical intrabronchial diluted epinephrine for the prevention of TBLB-related haemorrhage has not been explored in a prospective manner. Methods and analysis In this randomised, double-blind, placebo-controlled multicentre trial (PROPHET Study), single-lung and double-lung transplant adult recipients from participating institutions who are scheduled for bronchoscopy with TBLB for clinical indications will be identified. Potential participants who meet inclusion and exclusion criteria and sign an informed consent will be randomised to receive either diluted epinephrine or placebo prior to performance of TBLB. The degree of TBLB-related haemorrhage will be graded by the performing bronchoscopist as well as independent observers. The primary analysis will compare the rates of severe and very severe bleeding in participants treated with epinephrine or placebo. The study will also evaluate the safety profile of prophylactic topical epinephrine including the occurrence of serious cardiovascular and haemodynamic adverse events. Additional secondary outcomes to be explored include rates of non-severe TBLB-related haemorrhage, overall yield of the bronchoscopic procedure and non-serious cardiovascular and haemodynamic adverse effects. Ethics and dissemination The study procedures were reviewed and approved by institutional review boards in participating institutions. This study is being externally monitored, and a data and safety monitoring committee has been assembled to monitor patient safety and to evaluate the efficacy of the intervention. The results of this study will be published in peer-reviewed scientific journals and presented at relevant academic conferences. Trial registration number NCT03126968; Pre-results. Copyright Author(s) (or their employer(s)) 2019.
    Keyword
    bronchoscopy
    epinephrine
    haemorrhage
    lung transplantation
    transbronchial lung biopsy
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85063326492&doi=10.1136%2fbmjopen-2018-024521&partnerID=40&md5=339f333c55f27104156af683c67e8c11; http://hdl.handle.net/10713/10730
    ae974a485f413a2113503eed53cd6c53
    10.1136/bmjopen-2018-024521
    Scopus Count
    Collections
    UMB Open Access Articles 2019

    entitlement

    Related articles

    • Transbronchial biopsy results according to diffuse interstitial lung disease classification. Cryobiopsy versus forceps: MULTICRIO study.
    • Authors: Pajares V, Núñez-Delgado M, Bonet G, Pérez-Pallarés J, Martínez R, Cubero N, Zabala T, Cordovilla R, Flandes J, Disdier C, Torrego A, MULTICRIO Group researchers.
    • Issue date: 2020
    • Multicentre randomised controlled trial protocol of urine CXCL10 monitoring strategy in kidney transplant recipients.
    • Authors: Ho J, Sharma A, Kroeker K, Carroll R, De Serres S, Gibson IW, Hirt-Minkowski P, Jevnikar A, Kim SJ, Knoll G, Rush DN, Wiebe C, Nickerson P
    • Issue date: 2019 Apr 11
    • The higher risk of bleeding in lung transplant recipients from bronchoscopy is independent of traditional bleeding risks: results of a prospective cohort study.
    • Authors: Diette GB, Wiener CM, White P Jr
    • Issue date: 1999 Feb
    • Effectiveness and safety of Chinese herbal medicine xuanbi antong granules for the treatment of borderline coronary lesions: study protocol for a randomised, double-blinded, placebo-controlled, multicentre clinical trial.
    • Authors: Huang M, Chen G, Guan Q, Liu C, Zhao Q, Li J, Yao K, Zhang Z, He H, Li Y, Lin F, He X, Liu Y, Xiong XJ, Zhang Y, Han M, Wang J
    • Issue date: 2019 Aug 8
    • Prophylactic use of tranexamic acid for prevention of bleeding during transbronchial lung biopsies - A randomized, double-blind, placebo-controlled trial.
    • Authors: Kuint R, Levy L, Cohen Goichman P, Huszti E, Abu Rmeileh A, Shriki O, Abutbul A, Fridlender ZG, Berkman N
    • Issue date: 2020 Nov
    DSpace software (copyright © 2002 - 2021)  DuraSpace
    Quick Guide | Policies | Contact Us | UMB Health Sciences & Human Services Library
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.