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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.