Lung Transplant; Complications, MechanicalPhase 2/3PROPHETNCT03126968
Prophylactic Topical Epinephrine to Reduce Bleeding in Transbronchial Lung Biopsies
A Phase 2/3 study testing Topical epinephrine in people with Lung Transplant; Complications, Mechanical and Lung Transplant; Complications, run by University of Maryland, Baltimore at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant; Complications, Mechanical, Lung Transplant; Complications, Bleeding
- What is being tested?
- Topical epinephrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2017to 2 Jul 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age <18 years.
- Pregnancy.
- Inability to understand and provide a written informed consent.
- Platelet count <50 K/microL.
- International normalized ratio (INR) >1.5.
- Known bleeding diathesis.
Show all 34Show fewer
- 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 clinically significant ascites, clinical evidence of esophageal or gastric varices, or history of bleeding from gastric or esophageal varices.
- Prior history of TBLB-related airway bleeding requiring admission to the hospital or advanced measures to achieve hemostasis, including endotracheal intubation, bronchial blocker application, bronchial artery embolization, or surgical intervention.
- Systolic heart failure with an ejection fraction (EF) of <35% as assess by echocardiography performed within one year prior to the procedure.
- Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass surgery within 6 months prior to the procedure.
- Symptoms and/or ECG findings suggestive of ongoing cardiac ischemia on the day of the procedure.
- Moderate- to severe-grade cardiac valvulopathy as assessed by echocardiography performed within one year prior to the procedure.
- Inadequately controlled supraventricular arrhythmia, including atrial fibrillation, atrial flutter, and atrio-ventricular node re-entrant tachycardia (AVNRT) as revealed by ECG or cardiac monitoring at the time of the procedure.
- Presence of an internal cardioverter/defibrillator.
- History of second or third degree (complete) heart block or sick sinus syndrome.
- Baseline ECG or cardiac monitoring revealing frequent occurrence (≥10 events per minute) of atrial or ventricular ectopy documented prior to or at the time of the procedure.
- History of ventricular arrhythmias requiring pharmacologic or electrical cardioversion within the 2 years preceding the procedure.
- Serum potassium of <3.0 mmol/L within the week prior to the procedure.
- Serum glucose level of ≥300 mg/dL within the week prior to the procedure.
- Any history of critical ischemia related to peripheral arterial disease.
- Persistent resting heart rate (HR) measurement of ≥120 beats per minute prior to or at the time of the procedure.
- Persistent resting systolic blood pressure (SBP) measurement of ≥180 mm Hg prior to or at the time of the procedure.
- Persistent resting diastolic blood pressure (DBP) measurement of ≥110 mm Hg prior to or at the time of the procedure.
- History of acute closed-angle glaucoma within one year of the procedure.
- Diagnosis of pheochromocytoma requiring pharmacologic therapy with an alpha adrenoreceptor blocker at the time of the procedure.
- Diagnosis of thyrotoxicosis requiring pharmacologic therapy with an anti-thyroid agent at the time of the procedure.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Medical Center - Midtown Campus
Baltimore, Maryland, 21201
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Prophylactic Topical Epinephrine to Reduce Transbronchial Lung Biopsy-related Hemorrhage in Lung Transplant Recipients: a Prospective Double-blind Placebo-controlled Trial (PROPHylactic Epinephrine in Transbronchial Biopsy [PROPHET] Trial)
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.
Read the detailed description
The role of prophylactic topical epinephrine in improving hemostasis and prevention of clinically-significant pulmonary hemorrhage has never been studied formally in the past, despite its common use by pulmonologists performing bronchoscopic TBLB. Lung transplant recipients undergo multiple bronchoscopies and TBLBs for surveillance and evaluation of ACR as well as lung infection, especially during the first year post-transplantation. This population may have a predilection to TBLB-related bleeding and may benefit from measures to reduce the frequency and magnitude of this relatively common complication.
In the PROPHET trial, the investigators intend to assess the degree of biopsy-related bleeding, measures taken to control bleeding, and potential effects of bleeding on completion of the intended procedure in 50 bronchoscopy procedures performed on single and double lung transplant recipients, randomized to prophylactic topical epinephrine versus placebo (normal saline). The study participant, physician performing the TBLB, and independent observer reviewing the procedure recording will all be blinded to the randomization. Further use of measures to control bleeding that occurs during the procedure as well as the decision to complete the procedure as planned or to abort it prematurely will be left to the discretion of the performer. In this way, the investigators aim to elucidate a potential role of topical epinephrine in the prevention of TBLB-related airway bleeding in lung transplant recipients and assess whether the dose and volume of instillation used in the investigators' institution comprises an effective means to prevent hemorrhagic complications of TBLB.
HYPOTHESIS
The investigators hypothesize that prophylactic instillation of topical epinephrine prior to performance of TBLB will decrease the frequency and extent of biopsy-related hemorrhage as well as result in fewer procedures being aborted earlier than intended due to bleeding complications as well as shorter overall procedure time due to the preventive effect on bleeding. Concomitantly, the investigators hypothesize that the instillation of topical epinephrine will not be associated with a serious adverse event profile in comparison to placebo.
SPECIFIC AIMS
In this randomized-controlled double blind placebo controlled clinical trial post-lung transplant patients scheduled to receive bronchoscopy with TBLB as part of their routine standard of care will be randomized to receive a fixed dose and volume of topical endobronchial epinephrine versus matching volume of placebo which will be instilled into the target biopsy airway prior to performance of TBLB. This study will specifically aim at providing the following information:
Aim 1: Demonstrate the feasibility of assessments of bleeding related to TBLB, including:
- The degree of TBLB-related bleeding using a standardized grading scale used by the physician performing the procedure to quantify the degree of procedure-related bleeding.
- The degree of TBLB-related bleeding using a standardized grading scale used by two independent observers blinded to patient data and study drug assignment who will review a video recording of the procedure to quantify the degree of procedure-related bleeding.
- The magnitude of inter-observer variability in grading TBLB-related hemorrhage based on review of video recording of the procedure.
Aim 2: Evaluate the hypothesis that prophylactic administration of topical epinephrine results in reductions in TBLB-related hemorrhage in lung transplant recipients, including:
- The frequency of active measures taken to control pulmonary hemorrhage once it occurred.
- The proportion of procedures completed as planned in terms of obtaining a predefined target number of biopsy specimens.
- Comparison between single- and double-lung transplant recipients in terms of prevalence and degree of TBLB-related hemorrhage.
- Identification of clinical factors associated with an increased or decreased risk of procedure-related hemorrhage.
Aim 3: Evaluate the hypothesis that prophylactic administration of topical epinephrine affects the overall efficiency of bronchoscopy with TBLB performance, including:
- Overall duration of the bronchoscopic procedure.
- The proportion of procedures completed as planned in terms of number of adequate biopsies obtained as assessed by the physician performing the bronchoscopy.
- The proportion of procedures resulting in acquisition of adequate biopsy samples that allows proper pathologic evaluation of assignment of a pathologic diagnosis.
Aim 4: Explore the hypothesis that instillation of our prespecified dose and volume of topical epinephrine into the target biopsy airway is not associated with an adverse event profile that is significantly different from placebo, including:
- The prevalence of clinically significant hemodynamic changes.
- The prevalence of cardiac adverse events, including conduction abnormalities, arrhythmia, and myocardial ischemia.
- The prevalence of other vascular adverse events, including stroke, mesenteric ischemia, and critical limb ischemia.
- Identification of clinical factors associated with an increased or decreased risk of drug-related adverse events.
- Conditions
- Lung Transplant; Complications, Mechanical, Lung Transplant; Complications, Bleeding, Hemoptysis
- Being tested
- Topical epinephrine, Placebos
- Medical subject headings
- Hemorrhage, Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical epinephrineDrug
Prophylactic topical epinephrine
PlacebosDrug
Also called Placebo
Topical placebo (normal saline)
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic topical epinephrine | Experimental | Study participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical epinephrine in a blinded manner prior to performance of transbronchial lung biopsy. Receives: Drug: Topical epinephrine |
| Placebo | Placebo comparator | Study participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical placebo in the form of normal saline in a blinded manner prior to performance of transbronchial lung biopsy. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-procedural Hemorrhage Grading by the Performing Bronchoscopist
Intra-procedural hemorrhage will be graded by the performing bronchoscopist according to the following scale:
- No hemorrhage.
- Mild hemorrhage - Any bleeding originating from the biopsy target airway requiring wedging of the bronchoscope or "in and out" motion in order to achieve hemostasis.
- Moderate hemorrhage - Any bleeding originating from the biopsy target airway requiring in addition to maneuvering the bronchoscope application of iced saline or topical epinephrine or placing the patient with the bleeding lung in the dependent position.
- Severe hemorrhage - Any bleeding originating from the biopsy target airway requiring, in addition to the above-mentioned maneuvers, early termination of the procedure or necessitating application of balloon tamponade, endotracheal intubation, application of a bronchial blocker, or use of other invasive measures to achieve hemostasis, such as bronchial artery embolization or surgical intervention.
Measured: This outcome will be analyzed at the time of procedure performance and up to 48 hours following the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Jul 2017
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant; Complications, MechanicalStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert M Reed, University of Maryland, Baltimore
- Investigators
- Robert M Reed, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126968
- Sponsor's protocol ID
- HP-00070208
- Acronym
- PROPHET
- Status last verified
- Aug 2024
- First submitted
- 17 Apr 2017
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andersen HA, Fontana RS, Sanderson DR, Harrison EG Jr. Transbronchoscopic lung biopsy in diffuse pulmonary disease: results in 300 cases. Med Clin North Am. 1970 Jul;54(4):951-9. No abstract available.
PubMed 5425117Fletcher EC, Levin DC. Flexible fiberoptic bronchoscopy and fluoroscopically guided transbronchial biopsy in the management of solitary pulmonary nodules. West J Med. 1982 Jun;136(6):477-83.
PubMed 7113195Prakash UB, Offord KP, Stubbs SE. Bronchoscopy in North America: the ACCP survey. Chest. 1991 Dec;100(6):1668-75. doi: 10.1378/chest.100.6.1668.
PubMed 1959412Ahmad M, Livingston DR, Golish JA, Mehta AC, Wiedemann HP. The safety of outpatient transbronchial biopsy. Chest. 1986 Sep;90(3):403-5. doi: 10.1378/chest.90.3.403.
PubMed 3743154Hernandez Blasco L, Sanchez Hernandez IM, Villena Garrido V, de Miguel Poch E, Nunez Delgado M, Alfaro Abreu J. Safety of the transbronchial biopsy in outpatients. Chest. 1991 Mar;99(3):562-5. doi: 10.1378/chest.99.3.562.
PubMed 1995209Leslie KO, Gruden JF, Parish JM, Scholand MB. Transbronchial biopsy interpretation in the patient with diffuse parenchymal lung disease. Arch Pathol Lab Med. 2007 Mar;131(3):407-23. doi: 10.5858/2007-131-407-TBIITP.
PubMed 17516743Berbescu EA, Katzenstein AL, Snow JL, Zisman DA. Transbronchial biopsy in usual interstitial pneumonia. Chest. 2006 May;129(5):1126-31. doi: 10.1378/chest.129.5.1126.
PubMed 16685001Poletti V, Ravaglia C, Buccioli M, Tantalocco P, Piciucchi S, Dubini A, Carloni A, Chilosi M, Tomassetti S. Idiopathic pulmonary fibrosis: diagnosis and prognostic evaluation. Respiration. 2013;86(1):5-12. doi: 10.1159/000353580. Epub 2013 Jun 26.
PubMed 23816667Matthay RA, Farmer WC, Odero D. Diagnostic fibreoptic bronchoscopy in the immunocompromised host with pulmonary infiltrates. Thorax. 1977 Oct;32(5):539-45. doi: 10.1136/thx.32.5.539.
PubMed 594932Cazzadori A, Di Perri G, Todeschini G, Luzzati R, Boschiero L, Perona G, Concia E. Transbronchial biopsy in the diagnosis of pulmonary infiltrates in immunocompromised patients. Chest. 1995 Jan;107(1):101-6. doi: 10.1378/chest.107.1.101.
PubMed 7813258Gilman MJ, Wang KP. Transbronchial lung biopsy in sarcoidosis. An approach to determine the optimal number of biopsies. Am Rev Respir Dis. 1980 Nov;122(5):721-4. doi: 10.1164/arrd.1980.122.5.721.
PubMed 7447156Pinsker KL, Kamholz SL. Diagnosis of sarcoidosis by transbronchial lung biopsy. Chest. 1981 Jan;79(1):123-4. doi: 10.1378/chest.79.1.123b. No abstract available.
PubMed 7449494Talmage EA. Safe combined general and topical anesthesia for laryngoscopy and bronchoscopy. South Med J. 1973 Apr;66(4):455-9. doi: 10.1097/00007611-197304000-00015. No abstract available.
PubMed 4575235Kukafka DS, O'Brien GM, Furukawa S, Criner GJ. Surveillance bronchoscopy in lung transplant recipients. Chest. 1997 Feb;111(2):377-81. doi: 10.1378/chest.111.2.377.
PubMed 9041985Papin TA, Lynch JP 3rd, Weg JG. Transbronchial biopsy in the thrombocytopenic patient. Chest. 1985 Oct;88(4):549-52. doi: 10.1378/chest.88.4.549.
PubMed 4042705
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Topical Epinephrine to Reduce Transbronchial Lung Biopsy-related Hemorrhage in Lung Transplant Recipients: a Prospective Double-blind Placebo-controlled Trial (PROPHylactic Epinephrine in Transbronchial Biopsy [PROPHET] Trial)
- ClinicalTrials.gov ID
- NCT03126968
- Acronym / sponsor ID
- PROPHET / HP-00070208
- Conditions
- Lung Transplant; Complications, Mechanical, Lung Transplant; Complications, Bleeding, Hemoptysis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The role of prophylactic topical epinephrine in improving hemostasis and prevention of clinically-significant pulmonary hemorrhage has never been studied formally in the past, despite its common use by pulmonologists performing bronchoscopic TBLB. Lung transplant recipients undergo multiple bronchoscopies and TBLBs for surveillance and evaluation of ACR as well as lung infection, especially during the first year post-transplantation. This population may have a predilection to TBLB-related bleeding and may benefit from measures to reduce the frequency and magnitude of this relatively common complication.
In the PROPHET trial, the investigators intend to assess the degree of biopsy-related bleeding, measures taken to control bleeding, and potential effects of bleeding on completion of the intended procedure in 50 bronchoscopy procedures performed on single and double lung transplant recipients, randomized to prophylactic topical epinephrine versus placebo (normal saline). The study participant, physician performing the TBLB, and independent observer reviewing the procedure recording will all be blinded to the randomization. Further use of measures to control bleeding that occurs during the procedure as well as the decision to complete the procedure as planned or to abort it prematurely will be left to the discretion of the performer. In this way, the investigators aim to elucidate a potential role of topical epinephrine in the prevention of TBLB-related airway bleeding in lung transplant recipients and assess whether the dose and volume of instillation used in the investigators' institution comprises an effective means to prevent hemorrhagic complications of TBLB.
HYPOTHESIS
The investigators hypothesize that prophylactic instillation of topical epinephrine prior to performance of TBLB will decrease the frequency and extent of biopsy-related hemorrhage as well as result in fewer procedures being aborted earlier than intended due to bleeding complications as well as shorter overall procedure time due to the preventive effect on bleeding. Concomitantly, the investigators hypothesize that the instillation of topical epinephrine will not be associated with a serious adverse event profile in comparison to placebo.
SPECIFIC AIMS
In this randomized-controlled double blind placebo controlled clinical trial post-lung transplant patients scheduled to receive bronchoscopy with TBLB as part of their routine standard of care will be randomized to receive a fixed dose and volume of topical endobronchial epinephrine versus matching volume of placebo which will be instilled into the target biopsy airway prior to performance of TBLB. This study will specifically aim at providing the following information:
Aim 1: Demonstrate the feasibility of assessments of bleeding related to TBLB, including:
- The degree of TBLB-related bleeding using a standardized grading scale used by the physician performing the procedure to quantify the degree of procedure-related bleeding.
- The degree of TBLB-related bleeding using a standardized grading scale used by two independent observers blinded to patient data and study drug assignment who will review a video recording of the procedure to quantify the degree of procedure-related bleeding.
- The magnitude of inter-observer variability in grading TBLB-related hemorrhage based on review of video recording of the procedure.
Aim 2: Evaluate the hypothesis that prophylactic administration of topical epinephrine results in reductions in TBLB-related hemorrhage in lung transplant recipients, including:
- The frequency of active measures taken to control pulmonary hemorrhage once it occurred.
- The proportion of procedures completed as planned in terms of obtaining a predefined target number of biopsy specimens.
- Comparison between single- and double-lung transplant recipients in terms of prevalence and degree of TBLB-related hemorrhage.
- Identification of clinical factors associated with an increased or decreased risk of procedure-related hemorrhage.
Aim 3: Evaluate the hypothesis that prophylactic administration of topical epinephrine affects the overall efficiency of bronchoscopy with TBLB performance, including:
- Overall duration of the bronchoscopic procedure.
- The proportion of procedures completed as planned in terms of number of adequate biopsies obtained as assessed by the physician performing the bronchoscopy.
- The proportion of procedures resulting in acquisition of adequate biopsy samples that allows proper pathologic evaluation of assignment of a pathologic diagnosis.
Aim 4: Explore the hypothesis that instillation of our prespecified dose and volume of topical epinephrine into the target biopsy airway is not associated with an adverse event profile that is significantly different from placebo, including:
- The prevalence of clinically significant hemodynamic changes.
- The prevalence of cardiac adverse events, including conduction abnormalities, arrhythmia, and myocardial ischemia.
- The prevalence of other vascular adverse events, including stroke, mesenteric ischemia, and critical limb ischemia.
- Identification of clinical factors associated with an increased or decreased risk of drug-related adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic topical epinephrine | Experimental | Drug: Topical epinephrineStudy participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical epinephrine in a blinded manner prior to performance of transbronchial lung biopsy. |
| Placebo | Placebo comparator | Drug: PlacebosStudy participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical placebo in the form of normal saline in a blinded manner prior to performance of transbronchial lung biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (34 listed)
- Age <18 years.
- Pregnancy.
- Inability to understand and provide a written informed consent.
- Platelet count <50 K/microL.
- International normalized ratio (INR) >1.5.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical epinephrineProphylactic topical epinephrine | Drug | Prophylactic topical epinephrine |
| PlacebosAlso: PlaceboTopical placebo (normal saline) | Drug | Placebo |
Primary outcome
Intra-procedural Hemorrhage Grading by the Performing Bronchoscopist
Time frame: This outcome will be analyzed at the time of procedure performance and up to 48 hours following the procedure.
Intra-procedural hemorrhage will be graded by the performing bronchoscopist according to the following scale: 1. No hemorrhage. 2. Mild hemorrhage - Any bleeding originating from the biopsy target airway requiring wedging of the bronchoscope or "in and out" motion in order to achieve hemostasis. 3. Moderate hemorrhage - Any bleeding originating from the biopsy target airway requiring in addition to maneuvering the bronchoscope application of iced saline or topical epinephrine or placing the patient with the bleeding lung in the dependent position. 4. Severe hemorrhage - Any bleeding originating from the biopsy target airway requiring, in addition to the above-mentioned maneuvers, early termination of the procedure or necessitating application of balloon tamponade, endotracheal intubation, application of a bronchial blocker, or use of other invasive measures to achieve hemostasis, such as bronchial artery embolization or surgical intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 5425117Andersen HA, Fontana RS, Sanderson DR, Harrison EG Jr. Transbronchoscopic lung biopsy in diffuse pulmonary disease: results in 300 cases. Med Clin North Am. 1970 Jul;54(4):951-9. No abstract available.
- Background: PubMed 7113195Fletcher EC, Levin DC. Flexible fiberoptic bronchoscopy and fluoroscopically guided transbronchial biopsy in the management of solitary pulmonary nodules. West J Med. 1982 Jun;136(6):477-83.
- Background: PubMed 1959412Prakash UB, Offord KP, Stubbs SE. Bronchoscopy in North America: the ACCP survey. Chest. 1991 Dec;100(6):1668-75. doi: 10.1378/chest.100.6.1668.
- Background: PubMed 3743154Ahmad M, Livingston DR, Golish JA, Mehta AC, Wiedemann HP. The safety of outpatient transbronchial biopsy. Chest. 1986 Sep;90(3):403-5. doi: 10.1378/chest.90.3.403.
- Background: PubMed 1995209Hernandez Blasco L, Sanchez Hernandez IM, Villena Garrido V, de Miguel Poch E, Nunez Delgado M, Alfaro Abreu J. Safety of the transbronchial biopsy in outpatients. Chest. 1991 Mar;99(3):562-5. doi: 10.1378/chest.99.3.562.
- Background: PubMed 17516743Leslie KO, Gruden JF, Parish JM, Scholand MB. Transbronchial biopsy interpretation in the patient with diffuse parenchymal lung disease. Arch Pathol Lab Med. 2007 Mar;131(3):407-23. doi: 10.5858/2007-131-407-TBIITP.
- Background: PubMed 16685001Berbescu EA, Katzenstein AL, Snow JL, Zisman DA. Transbronchial biopsy in usual interstitial pneumonia. Chest. 2006 May;129(5):1126-31. doi: 10.1378/chest.129.5.1126.
- Background: PubMed 23816667Poletti V, Ravaglia C, Buccioli M, Tantalocco P, Piciucchi S, Dubini A, Carloni A, Chilosi M, Tomassetti S. Idiopathic pulmonary fibrosis: diagnosis and prognostic evaluation. Respiration. 2013;86(1):5-12. doi: 10.1159/000353580. Epub 2013 Jun 26.
- Background: PubMed 594932Matthay RA, Farmer WC, Odero D. Diagnostic fibreoptic bronchoscopy in the immunocompromised host with pulmonary infiltrates. Thorax. 1977 Oct;32(5):539-45. doi: 10.1136/thx.32.5.539.
- Background: PubMed 7813258Cazzadori A, Di Perri G, Todeschini G, Luzzati R, Boschiero L, Perona G, Concia E. Transbronchial biopsy in the diagnosis of pulmonary infiltrates in immunocompromised patients. Chest. 1995 Jan;107(1):101-6. doi: 10.1378/chest.107.1.101.
- Background: PubMed 7447156Gilman MJ, Wang KP. Transbronchial lung biopsy in sarcoidosis. An approach to determine the optimal number of biopsies. Am Rev Respir Dis. 1980 Nov;122(5):721-4. doi: 10.1164/arrd.1980.122.5.721.
- Background: PubMed 7449494Pinsker KL, Kamholz SL. Diagnosis of sarcoidosis by transbronchial lung biopsy. Chest. 1981 Jan;79(1):123-4. doi: 10.1378/chest.79.1.123b. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Reed, MD principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Topical epinephrine in people with Lung Transplant; Complications, Mechanical and Lung Transplant; Complications, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-procedural Hemorrhage Grading by the Performing Bronchoscopist (time frame: This outcome will be analyzed at the time of procedure performance and up to 48 hours following the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03126968, which also lists 58 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.