Prophylactic Topical Epinephrine to Reduce Bleeding in Transbronchial Lung Biopsies (NCT03126968) | Clinical Trial Compass
CompletedPhase 2/3
Prophylactic Topical Epinephrine to Reduce Bleeding in Transbronchial Lung Biopsies
United States66 participantsStarted 2017-07-01
Plain-language summary
Bleeding poses potential for significant complication after transbronchial lung biopsies. The investigators hypothesize that prophylactic intrabronchial instillation of topical epinephrine will reduce the likelihood of bleeding. The investigators plan a double-blind, placebo controlled trial to evaluate this hypothesis.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male and female subjects, ≥18 years of age.
* Single- or double-lung transplant recipients scheduled for bronchoscopy with TBLB.
* Willingness to sign an informed consent for study participation.
Exclusion Criteria:
* Age \<18 years.
* Pregnancy.
* Inability to understand and provide a written informed consent.
Exclusion criteria for TBLB:
* Platelet count \<50 K/microL.
* International normalized ratio (INR) \>1.5.
* Known bleeding diathesis.
* Use of prophylactic or therapeutic dose of unfractionated heparin within 6 hours of the procedure.
* Use of prophylactic dose of low molecular weight heparin within 12 hours of the procedure.
* Use of therapeutic dose of low molecular weight heparin within 24 hours of the procedure.
* Use of oral direct thrombin inhibitors or oral factor 10a inhibitors within 48 hours of the procedure.
* Use of clopidogrel, ticlopidine, ticagrelor, or prasugrel within 5 days of the procedure.
* Uremia, defined as estimated glomerular filtration rate (eGFR) ≤30 mL/min.
* Moderate to severe pulmonary hypertension as defined by a mean pulmonary artery pressure of \>40 mm Hg on right heart catheterization or an estimated pulmonary artery systolic pressure of \>62 mm Hg on transthoracic echocardiography, both performed within 1 year of the procedure.
* An additional synchronous procedure with possible bleeding (bronchoalveolar lavage and endobronchial biopsy allowed).
* Decompensated liver cirrhosis, defined as the presence of cl…
What they're measuring
1
Intra-procedural Hemorrhage Grading by the Performing Bronchoscopist
Timeframe: This outcome will be analyzed at the time of procedure performance and up to 48 hours following the procedure.