Prophylactic Topical Epinephrine to Reduce Bleeding in Transbronchial Lung Biopsies

NCT03126968 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HP-00070208
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lung Transplant; Complications, Mechanical; Lung Transplant; Complications; Bleeding; Hemoptysis

Outcome Measures

Primary Outcomes (1)

• Intra-procedural Hemorrhage Grading by the Performing Bronchoscopist

  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.

  This outcome will be analyzed at the time of procedure performance and up to 48 hours following the procedure.

Study Arms (2)

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.

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.

Drug: Placebos

Interventions

Topical epinephrine DRUG

Prophylactic topical epinephrine

Prophylactic topical epinephrine

Placebos DRUG

Topical placebo (normal saline)

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (2)

University of Maryland Medical Center - Midtown Campus

Baltimore, Maryland, 21201, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (58)

• 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: 5425117 BACKGROUND

• 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: 7113195 BACKGROUND

• 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: 1959412 BACKGROUND

• 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: 3743154 BACKGROUND

• 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: 1995209 BACKGROUND

• 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: 17516743 BACKGROUND

• 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: 16685001 BACKGROUND

• 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: 23816667 BACKGROUND

• 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: 594932 BACKGROUND

• 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: 7813258 BACKGROUND

• 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: 7447156 BACKGROUND

• 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: 7449494 BACKGROUND

• 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: 4575235 BACKGROUND

• 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: 9041985 BACKGROUND

• 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: 4042705 BACKGROUND

• Jain P, Sandur S, Meli Y, Arroliga AC, Stoller JK, Mehta AC. Role of flexible bronchoscopy in immunocompromised patients with lung infiltrates. Chest. 2004 Feb;125(2):712-22. doi: 10.1378/chest.125.2.712.

  PMID: 14769756 BACKGROUND

• Jabbardarjani H, Eslaminejad A, Mohammadtaheri Z, Kiani A, Arab A, Masjedi MR. The effect of cup versus alligator forceps on the results of transbronchial lung biopsy. J Bronchology Interv Pulmonol. 2010 Apr;17(2):117-21. doi: 10.1097/LBR.0b013e3181dc9920.

  PMID: 23168725 BACKGROUND

• Sehgal IS, Bal A, Dhooria S, Agrawal P, Gupta N, Ram B, Aggarwal AN, Behera D, Agarwal R. A Prospective Randomized Controlled Trial Comparing the Efficacy and Safety of Cup vs Alligator Forceps for Performing Transbronchial Lung Biopsy in Patients With Sarcoidosis. Chest. 2016 Jun;149(6):1584-6. doi: 10.1016/j.chest.2016.03.025. No abstract available.

  PMID: 27287583 BACKGROUND

• Flick MR, Wasson K, Dunn LJ, Block AJ. Fatal pulmonary hemorrhage after transbronchial lung biopsy through the fiberoptic bronchoscope. Am Rev Respir Dis. 1975 Jun;111(6):853-6. doi: 10.1164/arrd.1975.111.6.853.

  PMID: 1137250 BACKGROUND

• Chhajed PN, Aboyoun C, Malouf MA, Hopkins PM, Plit ML, Glanville AR. Risk factors and management of bleeding associated with transbronchial lung biopsy in lung transplant recipients. J Heart Lung Transplant. 2003 Feb;22(2):195-7. doi: 10.1016/s1053-2498(02)00462-x.

  PMID: 12581769 BACKGROUND

• Zavala DC. Diagnostic fiberoptic bronchoscopy: Techniques and results of biopsy in 600 patients. Chest. 1975 Jul;68(1):12-9. doi: 10.1378/chest.68.1.12.

  PMID: 168036 BACKGROUND

• Glanville AR. The role of surveillance bronchoscopy post-lung transplantation. Semin Respir Crit Care Med. 2013 Jun;34(3):414-20. doi: 10.1055/s-0033-1348466. Epub 2013 Jul 2.

  PMID: 23821514 BACKGROUND

• Sahebjami H. Letter: Iced saline lavage during bronchoscopy. Chest. 1976 Jan;69(1):131-2. doi: 10.1378/chest.69.1.131b. No abstract available.

  PMID: 1244274 BACKGROUND

• Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.

  PMID: 23860341 BACKGROUND

• Lee P, Mehta AC, Mathur PN. Management of complications from diagnostic and interventional bronchoscopy. Respirology. 2009 Sep;14(7):940-53. doi: 10.1111/j.1440-1843.2009.01617.x.

  PMID: 19740256 BACKGROUND

• Solomonov A, Fruchter O, Zuckerman T, Brenner B, Yigla M. Pulmonary hemorrhage: A novel mode of therapy. Respir Med. 2009 Aug;103(8):1196-200. doi: 10.1016/j.rmed.2009.02.004. Epub 2009 Feb 28.

  PMID: 19251406 BACKGROUND

• 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: 23168726 BACKGROUND

• 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: 19231404 BACKGROUND

• 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: 26210922 BACKGROUND

• 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: 11500350 BACKGROUND

• 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: 8901314 BACKGROUND

• 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. Chest. 1992 Oct;102(4):1049-54. doi: 10.1378/chest.102.4.1049.

  PMID: 1327662 BACKGROUND

• Baz MA, Layish DT, Govert JA, Howell DN, Lawrence CM, Davis RD, Tapson VF. Diagnostic yield of bronchoscopies after isolated lung transplantation. Chest. 1996 Jul;110(1):84-8. doi: 10.1378/chest.110.1.84.

  PMID: 8681672 BACKGROUND

• Timofte I, Terrin M, Barr E, Sanchez P, Kim J, Reed R, Britt E, Ravichandran B, Rajagopal K, Griffith B, Pham S, Pierson RN 3rd, Iacono A. Belatacept for renal rescue in lung transplant patients. Transpl Int. 2016 Apr;29(4):453-63. doi: 10.1111/tri.12731. Epub 2016 Feb 8.

  PMID: 26678245 BACKGROUND

• Chan CC, Abi-Saleh WJ, Arroliga AC, Stillwell PC, Kirby TJ, Gordon SM, Petras RE, Mehta AC. Diagnostic yield and therapeutic impact of flexible bronchoscopy in lung transplant recipients. J Heart Lung Transplant. 1996 Feb;15(2):196-205.

  PMID: 8672524 BACKGROUND

• 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: 24767387 BACKGROUND

• 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: 13441276 BACKGROUND

• Zamani A. Bronchoscopic intratumoral injection of tranexamic acid: a new technique for control of biopsy-induced bleeding. Blood Coagul Fibrinolysis. 2011 Jul;22(5):440-2. doi: 10.1097/MBC.0b013e328346efb7.

  PMID: 21577092 BACKGROUND

• Zamani A. Bronchoscopic intratumoral injection of tranexamic acid to prevent excessive bleeding during multiple forceps biopsies of lesions with a high risk of bleeding: a prospective case series. BMC Cancer. 2014 Mar 1;14:143. doi: 10.1186/1471-2407-14-143.

  PMID: 24581173 BACKGROUND

• Higgins TS, Hwang PH, Kingdom TT, Orlandi RR, Stammberger H, Han JK. Systematic review of topical vasoconstrictors in endoscopic sinus surgery. Laryngoscope. 2011 Feb;121(2):422-32. doi: 10.1002/lary.21286. Epub 2011 Jan 13.

  PMID: 21271600 BACKGROUND

• Valdes CJ, Bogado M, Rammal A, Samaha M, Tewfik MA. Topical cocaine vs adrenaline in endoscopic sinus surgery: a blinded randomized controlled study. Int Forum Allergy Rhinol. 2014 Aug;4(8):646-50. doi: 10.1002/alr.21325. Epub 2014 Mar 26.

  PMID: 24678064 BACKGROUND

• Fernandez-Cossio S, Rodriguez-Dinten MJ, Gude F, Fernandez-Alvarez JM. Topical Vasoconstrictors in Cosmetic Rhinoplasty: Comparative Evaluation of Cocaine Versus Epinephrine Solutions. Aesthetic Plast Surg. 2016 Oct;40(5):637-44. doi: 10.1007/s00266-016-0673-2. Epub 2016 Jun 29.

  PMID: 27357633 BACKGROUND

• Korkmaz H, Yao WC, Korkmaz M, Bleier BS. Safety and efficacy of concentrated topical epinephrine use in endoscopic endonasal surgery. Int Forum Allergy Rhinol. 2015 Dec;5(12):1118-23. doi: 10.1002/alr.21590. Epub 2015 Jul 8.

  PMID: 26152362 BACKGROUND

• Orlandi RR, Warrier S, Sato S, Han JK. Concentrated topical epinephrine is safe in endoscopic sinus surgery. Am J Rhinol Allergy. 2010 Mar-Apr;24(2):140-2. doi: 10.2500/ajra.2010.24.3454.

  PMID: 20338114 BACKGROUND

• Papp AA, Uusaro AV, Ruokonen ET. The effects of topical epinephrine on haemodynamics and markers of tissue perfusion in burned and non-burned patients requiring skin grafting. Burns. 2009 Sep;35(6):832-9. doi: 10.1016/j.burns.2008.10.001. Epub 2009 May 30.

  PMID: 19481869 BACKGROUND

• Kuster GG, Fischer B. Pharmacologic hemostasis in laparoscopy: topical epinephrine facilitates cholecystectomy. Am Surg. 1993 May;59(5):281-4.

  PMID: 8489094 BACKGROUND

• Roberts JR, Greenberg MI, Knaub MA, Kendrick ZV, Baskin SI. Blood levels following intravenous and endotracheal epinephrine administration. JACEP. 1979 Feb;8(2):53-6. doi: 10.1016/s0361-1124(79)80036-2.

  PMID: 439542 BACKGROUND

• Mazkereth R, Paret G, Ezra D, Aviner S, Peleg E, Rosenthal T, Barzilay Z. Epinephrine blood concentrations after peripheral bronchial versus endotracheal administration of epinephrine in dogs. Crit Care Med. 1992 Nov;20(11):1582-7. doi: 10.1097/00003246-199211000-00017.

  PMID: 1424703 BACKGROUND

• Mall W, Abel H. Topical application of epinephrine during bronchoscopy in barbiturate-halothane-anaesthesia and its influence on cardiac action. Bronchopneumologie. 1978 Jul-Aug;28(4):311-6.

  PMID: 92354 BACKGROUND

• Janjua M, Badshah A, Allen SA. Images in cardiology. Epinephrine-induced ST elevation: a case of endobronchial topical epinephrine-induced coronary vasospasm. Heart. 2009 Apr;95(8):656. doi: 10.1136/hrt.2008.161646. No abstract available.

  PMID: 19329720 BACKGROUND

• Steinfort DP, Herth FJ, Eberhardt R, Irving LB. Potentially fatal arrhythmia complicating endobronchial epinephrine for control of iatrogenic bleeding. Am J Respir Crit Care Med. 2012 May 1;185(9):1028-30. doi: 10.1164/ajrccm.185.9.1028. No abstract available.

  PMID: 22550217 BACKGROUND

• 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: 23675717 BACKGROUND

• 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: 23675719 BACKGROUND

• 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: 9259064 BACKGROUND

• 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: 10027438 BACKGROUND

• 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: 12398870 BACKGROUND

• 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: 37140517 DERIVED

• 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.

  PMID: 30904852 DERIVED

MeSH Terms

Conditions

Hemorrhage; Hemoptysis

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Robert M. Reed
• Organization: University of Maryland

rreed@som.umaryland.edu

4103288141

Study Officials

• Robert M Reed, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 25, 2017
• Study Start: July 1, 2017
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)