Prophylactic epinephrine attenuates severe bleeding in lung transplantation patients undergoing transbronchial lung biopsy: Results of the PROPHET randomized trial.

BACKGROUND: Severe hemorrhage is an uncommon yet potentially life-threatening complication of transbronchial lung biopsy. Lung transplantation recipients undergo multiple bronchoscopies with biopsy and are considered to be at an increased risk for bleeding from transbronchial biopsy, independent of traditional risk factors. We aimed to evaluate the efficacy and safety of endobronchial administration of prophylactic topical epinephrine in attenuating transbronchial biopsy-related hemorrhage in lung transplant recipients. METHODS: The Prophylactic Epinephrine for the Prevention of Transbronchial Lung Biopsy-related Bleeding in Lung Transplant Recipients study was a 2-center, randomized, double blind, placebo-controlled clinical trial. Participants undergoing transbronchial lung biopsy were randomized to receive 1:10,000-diluted topical epinephrine vs saline placebo administered prophylactically into the target segmental airway. Bleeding was graded based on a clinical severity scale. The primary efficacy outcome was incidence of severe or very severe hemorrhage. The primary safety outcome was a composite of 3-hours all-cause mortality and an acute cardiovascular event. RESULTS: A total of 66 lung transplantation recipients underwent 100 bronchoscopies during the study period. The primary outcome of severe or very severe hemorrhage occurred in 4 cases (8%) in the prophylactic epinephrine group and in 13 cases (24%) in the control group (p = 0.04). The composite primary safety outcome did not occur in any of the study groups. CONCLUSIONS: In lung transplantation recipients undergoing transbronchial lung biopsy, prophylactic administration of 1:10,000-diluted topical epinephrine into the target segmental airway before biopsy attenuates the incidence of significant endobronchial hemorrhage without conveying a significant cardiovascular risk. (ClinicalTrials.gov identifier: NCT03126968).

Intrapleural Alteplase and Dornase in a Pregnant Woman With Complicated Parapneumonic Effusion.

The use of intrapleural alteplase and dornase in pregnant patients remains an uncertain practice because bleeding complications in these cases could be devastating. We present a case in which we successfully used a modified protocol safely.

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.

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.

Human papillomavirus vaccine decision-making in Da Nang, Vietnam: perceived spousal and adolescent-parent concordance.

This descriptive study examined parents' perceptions of the role of mothers, fathers, and daughters in the decision to have their daughter receive the human papillomavirus (HPV) vaccine; perceived concordance between spouses and between parents and daughters; and the relationships between vaccine decision-making and (1) who takes the daughter to the doctor, and (2) the daughter's age. Health care workers (N=139) with a daughter 9-21 years old completed a self-administered questionnaire including demographic and HPV vaccine-related questions. Health care workers were employed by Da Nang General Hospital or the Da Nang Center for Reproductive Health Care in Vietnam. Most (73%) parents favored having their daughter receive the HPV vaccine and 84% would consult their spouse about having their daughter vaccinated. Sixty-six percent of parents believed that HPV vaccination should be a joint decision involving both parents and the daughter. Parents perceived concordance between themselves and their spouse, with 91% agreement between their own decision and what they thought their spouse would decide; less concordance (77%) was observed between themselves and what they thought their daughter would want. Most (87% of mothers and 62% of fathers) would consider his/her spouse's opinion in the decision regarding HPV vaccination when accompanying the daughter to a health care visit in the absence of the spouse. Perceived spousal concordance was 94% for parents of daughters under the age of consent in Vietnam (16 years). Decisions regarding HPV vaccination will likely be made jointly by parents and adolescents. Educating fathers about HPV vaccination may be important.