Abstract
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 (PROPHET) study was a two-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-hour 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
prior to biopsy attenuates the incidence of significant endobronchial hemorrhage without
conveying a significant cardiovascular risk. (ClinicalTrials.gov identifier: NCT03126968).
Key words
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Article info
Publication history
Publication stage
In Press Journal Pre-ProofFootnotes
The PROPHET Trial individual, de-identified participant data will be shared upon request. Shared data will include all individual participant data collected during the study after de-identification. The case report form template will also be made available for sharing. The data will be available for sharing for 5 years from the official date of publication. Requests for the PROPHET de-identified data should be directed to Dr. Robert M. Reed ([email protected]). Requests should be accompanied by an analysis and publication proposal and requestors will be required to sign a data access agreement.
Identification
Copyright
© Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation.
