Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-02-22 @ 9:54 AM
Study NCT ID:
NCT03126968
Status:
COMPLETED
Last Update Posted:
2024-08-28
First Post:
2017-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prophylactic Topical Epinephrine to Reduce Bleeding in Transbronchial Lung Biopsies
Sponsor:
Organization:
Raw JSON
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Reed', 'organization': 'University of Maryland'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '48 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Prophylactic Topical Epinephrine', 'description': '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.\n\nTopical epinephrine: Prophylactic topical epinephrine', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 16, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': '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.\n\nPlacebos: Topical placebo (normal saline)', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 18, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Drop in BP >20 from baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumothorax', 'notes': 'Iatrogenic pneumothorx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxemic respiratory failure', 'notes': 'Deterioration requiring escalation of care (admission to hospital in both cases)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intra-procedural Hemorrhage Grading by the Performing Bronchoscopist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'units': 'Procedures', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prophylactic Topical Epinephrine', 'description': '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.\n\nTopical epinephrine: Prophylactic topical epinephrine'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.\n\nPlacebos: Topical placebo (normal saline)'}], 'classes': [{'title': 'Severe or very severe hemorrhage', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Moderate, severe, or very severe hemorrhage', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Unblinded administration of epinephrine for bleeding', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Early termination of the procedure due to bleeding', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'This outcome will be analyzed at the time of procedure performance and up to 48 hours following the procedure.', 'description': 'Intra-procedural hemorrhage will be graded by the performing bronchoscopist according to the following scale:\n\n1. No hemorrhage.\n2. 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.\n3. 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.\n4. 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.', 'unitOfMeasure': 'Procedures', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prophylactic Topical Epinephrine', 'description': '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.\n\nTopical epinephrine: Prophylactic topical epinephrine'}, {'id': 'FG001', 'title': 'Placebo', 'description': '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.\n\nPlacebos: Topical placebo (normal saline)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '46', 'numSubjects': '33'}, {'groupId': 'FG001', 'numUnits': '54', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '46', 'numSubjects': '33'}, {'groupId': 'FG001', 'numUnits': '54', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Procedures', 'recruitmentDetails': 'Eligible patients undergoing bronchoscopy with transbronchial biopsies after lung transplantation were offered participation in the study.', 'preAssignmentDetails': 'Patients not meeting eligibility criteria were not included. Informed consent was obtained immediately prior to the procedure. Patients were randomized in a double-blind, placebo-controlled fashion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'units': 'Procedures', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prophylactic Topical Epinephrine', 'description': '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.\n\nTopical epinephrine: Prophylactic topical epinephrine'}, {'id': 'BG001', 'title': 'Placebo', 'description': '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.\n\nPlacebos: Topical placebo (normal saline)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '68'}, {'value': '64', 'groupId': 'BG001', 'lowerLimit': '56', 'upperLimit': '68'}, {'value': '63.5', 'groupId': 'BG002', 'lowerLimit': '56', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race / Ethnicity', 'categories': [{'title': 'African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Caucasian', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Procedures', 'populationDescription': 'Study consisted of 100 procedures performed on 66 participants as participants were permitted to participate more than once.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-23', 'size': 425823, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-23T13:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2017-04-17', 'resultsFirstSubmitDate': '2023-01-24', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-23', 'studyFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'description': 'Intra-procedural hemorrhage will be graded by the performing bronchoscopist according to the following scale:\n\n1. No hemorrhage.\n2. 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.\n3. 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.\n4. 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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Transplant; Complications, Mechanical', 'Lung Transplant; Complications', 'Bleeding', 'Hemoptysis']}, 'referencesModule': {'references': [{'pmid': '5425117', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7113195', 'type': 'BACKGROUND', 'citation': 'Fletcher 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.'}, {'pmid': '1959412', 'type': 'BACKGROUND', 'citation': 'Prakash 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.'}, {'pmid': '3743154', 'type': 'BACKGROUND', 'citation': 'Ahmad 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.'}, {'pmid': '1995209', 'type': 'BACKGROUND', 'citation': 'Hernandez 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.'}, {'pmid': '17516743', 'type': 'BACKGROUND', 'citation': 'Leslie 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.'}, {'pmid': '16685001', 'type': 'BACKGROUND', 'citation': 'Berbescu 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.'}, {'pmid': '23816667', 'type': 'BACKGROUND', 'citation': 'Poletti 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.'}, {'pmid': '594932', 'type': 'BACKGROUND', 'citation': 'Matthay 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.'}, {'pmid': '7813258', 'type': 'BACKGROUND', 'citation': 'Cazzadori 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.'}, {'pmid': '7447156', 'type': 'BACKGROUND', 'citation': 'Gilman 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.'}, {'pmid': '7449494', 'type': 'BACKGROUND', 'citation': 'Pinsker 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.'}, {'pmid': '4575235', 'type': 'BACKGROUND', 'citation': 'Talmage 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.'}, {'pmid': '9041985', 'type': 'BACKGROUND', 'citation': "Kukafka 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."}, {'pmid': '4042705', 'type': 'BACKGROUND', 'citation': 'Papin 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.'}, {'pmid': '14769756', 'type': 'BACKGROUND', 'citation': 'Jain P, Sandur S, Meli Y, Arroliga AC, Stoller JK, Mehta AC. Role of flexible bronchoscopy in immunocompromised patients with lung infiltrates. 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Respir Med. 2009 Aug;103(8):1196-200. doi: 10.1016/j.rmed.2009.02.004. Epub 2009 Feb 28.'}, {'pmid': '23168726', 'type': 'BACKGROUND', 'citation': 'Marquez-Martin E, Vergara DG, Martin-Juan J, Flacon AR, Lopez-Campos JL, Rodriguez-Panadero F. Endobronchial administration of tranexamic Acid for controlling pulmonary bleeding: a pilot study. J Bronchology Interv Pulmonol. 2010 Apr;17(2):122-5. doi: 10.1097/LBR.0b013e3181dc8c17.'}, {'pmid': '19231404', 'type': 'BACKGROUND', 'citation': 'Shigemura N, Wan IY, Yu SC, Wong RH, Hsin MK, Thung HK, Lee TW, Wan S, Underwood MJ, Yim AP. Multidisciplinary management of life-threatening massive hemoptysis: a 10-year experience. Ann Thorac Surg. 2009 Mar;87(3):849-53. doi: 10.1016/j.athoracsur.2008.11.010.'}, {'pmid': '26210922', 'type': 'BACKGROUND', 'citation': 'Yendamuri S. Massive Airway Hemorrhage. Thorac Surg Clin. 2015 Aug;25(3):255-60. doi: 10.1016/j.thorsurg.2015.04.009. Epub 2015 Jun 12.'}, {'pmid': '11500350', 'type': 'BACKGROUND', 'citation': 'Aboyoun CL, Tamm M, Chhajed PN, Hopkins P, Malouf MA, Rainer S, Glanville AR. Diagnostic value of follow-up transbronchial lung biopsy after lung rejection. Am J Respir Crit Care Med. 2001 Aug 1;164(3):460-3. doi: 10.1164/ajrccm.164.3.2011152.'}, {'pmid': '8901314', 'type': 'BACKGROUND', 'citation': 'Vitulo P, Cremaschi P, Arbustini E, Volpato G, Volpini E, Martinelli L, Fracchia C, Rossi A. Surveillance transbronchial biopsy in the diagnosis of acute lung rejection in heart and lung and lung transplant recipients. Monaldi Arch Chest Dis. 1996 Feb;51(1):12-5.'}, {'pmid': '1327662', 'type': 'BACKGROUND', 'citation': 'Trulock EP, Ettinger NA, Brunt EM, Pasque MK, Kaiser LR, Cooper JD. The role of transbronchial lung biopsy in the treatment of lung transplant recipients. An analysis of 200 consecutive procedures. 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J Heart Lung Transplant. 1996 Feb;15(2):196-205.'}, {'pmid': '24767387', 'type': 'BACKGROUND', 'citation': 'Inoue M, Minami M, Wada N, Nakagiri T, Funaki S, Kawamura T, Shintani Y, Okumura M. Results of surveillance bronchoscopy after cadaveric lung transplantation: a Japanese single-institution study. Transplant Proc. 2014 Apr;46(3):944-7. doi: 10.1016/j.transproceed.2013.10.055.'}, {'pmid': '13441276', 'type': 'BACKGROUND', 'citation': 'GOGERTY JH, STRAND HA, OGILVIE AL, DILLE JM. Vasopressor effects of topical epinephrine in certain dental procedures. Oral Surg Oral Med Oral Pathol. 1957 Jun;10(6):614-22. doi: 10.1016/s0030-4220(57)80009-7. No abstract available.'}, {'pmid': '21577092', 'type': 'BACKGROUND', 'citation': 'Zamani A. Bronchoscopic intratumoral injection of tranexamic acid: a new technique for control of biopsy-induced bleeding. 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No abstract available.'}, {'pmid': '23675717', 'type': 'BACKGROUND', 'citation': 'Khoo KL, Lee P, Mehta AC. Endobronchial epinephrine: confusion is in the air. Am J Respir Crit Care Med. 2013 May 15;187(10):1137-8. doi: 10.1164/rccm.201209-1682LE. No abstract available.'}, {'pmid': '23675719', 'type': 'BACKGROUND', 'citation': 'Steinfort DP, Herth FJ, Eberhardt R, Irving LB. Reply: Endobronchial epinephrine: confusion is in the air. Am J Respir Crit Care Med. 2013 May 15;187(10):1138. doi: 10.1164/rccm.201301-0123LE. No abstract available.'}, {'pmid': '9259064', 'type': 'BACKGROUND', 'citation': 'Paret G, Vaknin Z, Ezra D, Peleg E, Rosenthal T, Vardi A, Mayan H, Barzilay Z. Epinephrine pharmacokinetics and pharmacodynamics following endotracheal administration in dogs: the role of volume of diluent. Resuscitation. 1997 Aug;35(1):77-82. doi: 10.1016/s0300-9572(96)01091-x.'}, {'pmid': '10027438', 'type': 'BACKGROUND', 'citation': 'Diette GB, Wiener CM, White P Jr. The higher risk of bleeding in lung transplant recipients from bronchoscopy is independent of traditional bleeding risks: results of a prospective cohort study. Chest. 1999 Feb;115(2):397-402. doi: 10.1378/chest.115.2.397.'}, {'pmid': '12398870', 'type': 'BACKGROUND', 'citation': 'Hopkins PM, Aboyoun CL, Chhajed PN, Malouf MA, Plit ML, Rainer SP, Glanville AR. Prospective analysis of 1,235 transbronchial lung biopsies in lung transplant recipients. J Heart Lung Transplant. 2002 Oct;21(10):1062-7. doi: 10.1016/s1053-2498(02)00442-4.'}, {'pmid': '37140517', 'type': 'DERIVED', 'citation': 'Kalchiem-Dekel O, Tran BC, Glick DR, Ha NT, Iacono A, Pickering EM, Shah NG, Sperry MG, Sachdeva A, Reed RM. Prophylactic epinephrine attenuates severe bleeding in lung transplantation patients undergoing transbronchial lung biopsy: Results of the PROPHET randomized trial. J Heart Lung Transplant. 2023 Sep;42(9):1205-1213. doi: 10.1016/j.healun.2023.03.007. Epub 2023 Mar 14.'}, {'pmid': '30904852', 'type': 'DERIVED', 'citation': 'Kalchiem-Dekel O, Iacono A, Pickering EM, Sachdeva A, Shah NG, Sperry M, Tran BC, Reed RM. 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. BMJ Open. 2019 Mar 23;9(3):e024521. doi: 10.1136/bmjopen-2018-024521.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIn 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.\n\nHYPOTHESIS\n\nThe 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.\n\nSPECIFIC AIMS\n\nIn 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:\n\nAim 1: Demonstrate the feasibility of assessments of bleeding related to TBLB, including:\n\n1. 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.\n2. 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.\n3. The magnitude of inter-observer variability in grading TBLB-related hemorrhage based on review of video recording of the procedure.\n\nAim 2: Evaluate the hypothesis that prophylactic administration of topical epinephrine results in reductions in TBLB-related hemorrhage in lung transplant recipients, including:\n\n1. The frequency of active measures taken to control pulmonary hemorrhage once it occurred.\n2. The proportion of procedures completed as planned in terms of obtaining a predefined target number of biopsy specimens.\n3. Comparison between single- and double-lung transplant recipients in terms of prevalence and degree of TBLB-related hemorrhage.\n4. Identification of clinical factors associated with an increased or decreased risk of procedure-related hemorrhage.\n\nAim 3: Evaluate the hypothesis that prophylactic administration of topical epinephrine affects the overall efficiency of bronchoscopy with TBLB performance, including:\n\n1. Overall duration of the bronchoscopic procedure.\n2. The proportion of procedures completed as planned in terms of number of adequate biopsies obtained as assessed by the physician performing the bronchoscopy.\n3. The proportion of procedures resulting in acquisition of adequate biopsy samples that allows proper pathologic evaluation of assignment of a pathologic diagnosis.\n\nAim 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:\n\n1. The prevalence of clinically significant hemodynamic changes.\n2. The prevalence of cardiac adverse events, including conduction abnormalities, arrhythmia, and myocardial ischemia.\n3. The prevalence of other vascular adverse events, including stroke, mesenteric ischemia, and critical limb ischemia.\n4. Identification of clinical factors associated with an increased or decreased risk of drug-related adverse events."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects, ≥18 years of age.\n* Single- or double-lung transplant recipients scheduled for bronchoscopy with TBLB.\n* Willingness to sign an informed consent for study participation.\n\nExclusion Criteria:\n\n* Age \\<18 years.\n* Pregnancy.\n* Inability to understand and provide a written informed consent.\n\nExclusion criteria for TBLB:\n\n* Platelet count \\<50 K/microL.\n* International normalized ratio (INR) \\>1.5.\n* Known bleeding diathesis.\n* Use of prophylactic or therapeutic dose of unfractionated heparin within 6 hours of the procedure.\n* Use of prophylactic dose of low molecular weight heparin within 12 hours of the procedure.\n* Use of therapeutic dose of low molecular weight heparin within 24 hours of the procedure.\n* Use of oral direct thrombin inhibitors or oral factor 10a inhibitors within 48 hours of the procedure.\n* Use of clopidogrel, ticlopidine, ticagrelor, or prasugrel within 5 days of the procedure.\n* Uremia, defined as estimated glomerular filtration rate (eGFR) ≤30 mL/min.\n* 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.\n* An additional synchronous procedure with possible bleeding (bronchoalveolar lavage and endobronchial biopsy allowed).\n* 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.\n* 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.\n\nExclusion criteria for application of topical epinephrine:\n\n* Systolic heart failure with an ejection fraction (EF) of \\<35% as assess by echocardiography performed within one year prior to the procedure.\n* Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass surgery within 6 months prior to the procedure.\n* Symptoms and/or ECG findings suggestive of ongoing cardiac ischemia on the day of the procedure.\n* Moderate- to severe-grade cardiac valvulopathy as assessed by echocardiography performed within one year prior to the procedure.\n* 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.\n* Presence of an internal cardioverter/defibrillator.\n* History of second or third degree (complete) heart block or sick sinus syndrome.\n* 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.\n* History of ventricular arrhythmias requiring pharmacologic or electrical cardioversion within the 2 years preceding the procedure.\n* Serum potassium of \\<3.0 mmol/L within the week prior to the procedure.\n* Serum glucose level of ≥300 mg/dL within the week prior to the procedure.\n* Any history of critical ischemia related to peripheral arterial disease.\n* Persistent resting heart rate (HR) measurement of ≥120 beats per minute prior to or at the time of the procedure.\n* Persistent resting systolic blood pressure (SBP) measurement of ≥180 mm Hg prior to or at the time of the procedure.\n* Persistent resting diastolic blood pressure (DBP) measurement of ≥110 mm Hg prior to or at the time of the procedure.\n* History of acute closed-angle glaucoma within one year of the procedure.\n* Diagnosis of pheochromocytoma requiring pharmacologic therapy with an alpha adrenoreceptor blocker at the time of the procedure.\n* Diagnosis of thyrotoxicosis requiring pharmacologic therapy with an anti-thyroid agent at the time of the procedure.'}, 'identificationModule': {'nctId': 'NCT03126968', 'acronym': 'PROPHET', 'briefTitle': 'Prophylactic Topical Epinephrine to Reduce Bleeding in Transbronchial Lung Biopsies', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'HP-00070208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prophylactic topical epinephrine', 'description': '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.', 'interventionNames': ['Drug: Topical epinephrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Topical epinephrine', 'type': 'DRUG', 'description': 'Prophylactic topical epinephrine', 'armGroupLabels': ['Prophylactic topical epinephrine']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Topical placebo (normal saline)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center - Midtown Campus', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Robert M Reed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Robert M Reed', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}