Bronchial Artery Embolization and Medical Measures in Non Severe Acute Hemoptysis of Mild-moderate Abundance

Acute Disease Clinical Trial

— ARTEMHYS  

Official title:

A Multicentric Randomized Trial Comparing the Bronchial Artery Embolization Combined With Medical Measures and the Medical Measures Alone in the Treatment of Non-severe Acute Hemoptysis of Mild-to-moderate Abundance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278199
• Other study ID #: K081202
• Status: Completed
• Phase: N/A
• First received: January 14, 2011
• Last updated: March 21, 2017
• Start date: November 2011
• Est. completion date: February 27, 2017

Study information

• Verified date: March 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Severe hemoptysis is a life-threatening condition, with an unpredictable course. The efficacy of bronchial artery embolization (BAE) is well established for the treatment of severe hemoptysis, with short and long-term bleeding controls obtained in 70 to 100% and 50 to 90% of cases, respectively. As complications related to vascular interventional radiology may occur in 5 to 10% of cases, the benefit-risk balance might be less clear in acute hemoptysis of mild-to-moderate abundance (volume between 100 and 200 ml) and no criteria of severity (respiratory failure or hemodynamic instability). There is no available data comparing the safety and efficacy of BAE combined with medical measures to those of medical measures alone in the treatment of non-severe acute hemoptysis of mild-to-moderate abundance.

Description:

The study is a multicentric (n=8) randomized study, involving two parallel groups of patients with non-severe acute hemoptysis of mild-to-moderate abundance, related to a systemic bronchial or non-bronchial hypervascularization, and comparing the bronchial artery embolization combined with medical measures and the medical measures alone in this field.

The primary aim of the study is to evaluate the efficacy of BAE combined with medical measures in the treatment of non-severe acute hemoptysis of mild-to-moderate abundance, as compared with that of medical measures alone, by assessing the percentage of recurrence of hemoptysis at one month. Bleeding recurrence is defined as a volume of blood expectorated of at least 50 ml.

The second objectives of the study are to compare the efficacy of the two strategies at 3 months and to assess the safety of both strategies during hospitalization and follow-up.

Based on a previous study of our group (Reference 8), the number of patients in each group is 105, assuming a one-month bleeding recurrence rate of 11% in the group receiving BAE, as compared with 26% in the group assisted medically (a=.05; β=0.8).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 27, 2017
• Est. primary completion date: December 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-severe acute hemoptysis (mild-to-moderate abundance and no criteria of severity).

• Age > 18 years

• Patients with social insurance

Exclusion Criteria:

• Pregnant and/or lactating women

• Traumatic hemoptysis

• Severe hemoptysis (volume > 200 ml; respiratory failure; hemodynamic instability)

• Patients already enrolled in the study within the preceding 3 months

• Patients in palliative care, for whom there is no therapeutic plan at short-term

• Moribund patients

Related Conditions & MeSH terms

• Acute Disease
• Hemoptysis

Intervention

Other:
• Medicals measures
Rest in bed. Monitoring of respiratory frequency. Fixation of intravenous route. Administration of nasal oxygenotherapy in order to maintain SpO2 > 90%. Administration of antituberculosis treatment, in case with active pulmonary tuberculosis known at admission or diagnosed during the stay. If necessary a bronchial wash out of will be realized by a bronchial fibroscopy with measures of use of cold serum, adrenalin xylocain or terlipressin. The administration of antibiotherapy by general mode according to the clinician appreciation. The administration of terlipressin according to the clinician appreciation. Against the cough treatment administration according to the clinician appreciation.
• bronchial artery embolization
The bronchial artery embolization is practised within 48 hours which follow the hospital admission for non-severe acute hemoptysis.

Locations

Country	Name	City	State
France	Tenon Hospital, AP-HP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (40)

Bruzzi JF, Rémy-Jardin M, Delhaye D, Teisseire A, Khalil C, Rémy J. Multi-detector row CT of hemoptysis. Radiographics. 2006 Jan-Feb;26(1):3-22. Review. — View Citation

Cremaschi P, Nascimbene C, Vitulo P, Catanese C, Rota L, Barazzoni GC, Cornalba GP. Therapeutic embolization of bronchial artery: a successful treatment in 209 cases of relapse hemoptysis. Angiology. 1993 Apr;44(4):295-9. — View Citation

Crocco JA, Rooney JJ, Fankushen DS, DiBenedetto RJ, Lyons HA. Massive hemoptysis. Arch Intern Med. 1968 Jun;121(6):495-8. — View Citation

Dweik RA, Stoller JK. Role of bronchoscopy in massive hemoptysis. Clin Chest Med. 1999 Mar;20(1):89-105. Review. — View Citation

Fartoukh M, Khalil A, Louis L, Carette MF, Bazelly B, Cadranel J, Mayaud C, Parrot A. An integrated approach to diagnosis and management of severe haemoptysis in patients admitted to the intensive care unit: a case series from a referral centre. Respir Res. 2007 Feb 15;8:11. — View Citation

Garzon AA, Cerruti MM, Golding ME. Exsanguinating hemoptysis. J Thorac Cardiovasc Surg. 1982 Dec;84(6):829-33. — View Citation

Håkanson E, Konstantinov IE, Fransson SG, Svedjeholm R. Management of life-threatening haemoptysis. Br J Anaesth. 2002 Feb;88(2):291-5. — View Citation

Haponik EF, Chin R. Hemoptysis: clinicians' perspectives. Chest. 1990 Feb;97(2):469-75. — View Citation

Haponik EF, Fein A, Chin R. Managing life-threatening hemoptysis: has anything really changed? Chest. 2000 Nov;118(5):1431-5. — View Citation

Hayakawa K, Tanaka F, Torizuka T, Mitsumori M, Okuno Y, Matsui A, Satoh Y, Fujiwara K, Misaki T. Bronchial artery embolization for hemoptysis: immediate and long-term results. Cardiovasc Intervent Radiol. 1992 May-Jun;15(3):154-8; discussion 158-9. — View Citation

Hirshberg B, Biran I, Glazer M, Kramer MR. Hemoptysis: etiology, evaluation, and outcome in a tertiary referral hospital. Chest. 1997 Aug;112(2):440-4. — View Citation

JACKSON GG, ARANA-SIALER JA, ANDERSEN BR GRIEBLE HG, McCABE WR. Profiles of pyelonephritis. Arch Intern Med. 1962 Nov;110:63-75. — View Citation

Jean-Baptiste E. Clinical assessment and management of massive hemoptysis. Crit Care Med. 2000 May;28(5):1642-7. Review. — View Citation

Jewkes J, Kay PH, Paneth M, Citron KM. Pulmonary aspergilloma: analysis of prognosis in relation to haemoptysis and survey of treatment. Thorax. 1983 Aug;38(8):572-8. — View Citation

Khalil A, Parrot A, Nedelcu C, Fartoukh M, Marsault C, Carette MF. Severe hemoptysis of pulmonary arterial origin: signs and role of multidetector row CT angiography. Chest. 2008 Jan;133(1):212-9. — View Citation

Knott-Craig CJ, Oostuizen JG, Rossouw G, Joubert JR, Barnard PM. Management and prognosis of massive hemoptysis. Recent experience with 120 patients. J Thorac Cardiovasc Surg. 1993 Mar;105(3):394-7. — View Citation

Labbe V, Roques S, Boughdène F, Razazi K, Khalil A, Parrot A, Fartoukh M. Shock complicating successful bronchial artery embolization for severe hemoptysis. Chest. 2009 Jan;135(1):215-7. doi: 10.1378/chest.08-0491. — View Citation

Lacerda JE, Consolim-Colombo FM, Moreira ED, Ida F, Silva GJ, Irigoyen MC, Krieger EM. Influence of cardiopulmonary reflex on the sympathetic activity during myocardial infarction. Auton Neurosci. 2007 May 30;133(2):128-35. — View Citation

Lordan JL, Gascoigne A, Corris PA. The pulmonary physician in critical care * Illustrative case 7: Assessment and management of massive haemoptysis. Thorax. 2003 Sep;58(9):814-9. Review. — View Citation

Mal H, Rullon I, Mellot F, Brugière O, Sleiman C, Menu Y, Fournier M. Immediate and long-term results of bronchial artery embolization for life-threatening hemoptysis. Chest. 1999 Apr;115(4):996-1001. — View Citation

Mal H. [Role of surgery in the management of severe haemoptysis]. Rev Mal Respir. 2005 Nov;22(5 Pt 1):717-9. French. — View Citation

Mesurolle B, Lacombe P, Barre O, Qanadli S, Mulot RO, Chagnon S. [Failures and complications of bronchial artery embolization]. Rev Mal Respir. 1996 Jul;13(3):217-25. Review. French. — View Citation

Ong TH, Eng P. Massive hemoptysis requiring intensive care. Intensive Care Med. 2003 Feb;29(2):317-20. — View Citation

Picard C, Parrot A, Boussaud V, Lavolé A, Saidi F, Mayaud C, Carette MF. Massive hemoptysis due to Rasmussen aneurysm: detection with helicoidal CT angiography and successful steel coil embolization. Intensive Care Med. 2003 Oct;29(10):1837-9. — View Citation

PURSEL SE, LINDSKOG GE. Hemoptysis. A clinical evaluation of 105 patients examined consecutively on a thoracic surgical service. Am Rev Respir Dis. 1961 Sep;84:329-36. — View Citation

Rabkin JE, Astafjev VI, Gothman LN, Grigorjev YG. Transcatheter embolization in the management of pulmonary hemorrhage. Radiology. 1987 May;163(2):361-5. — View Citation

Ramakantan R, Bandekar VG, Gandhi MS, Aulakh BG, Deshmukh HL. Massive hemoptysis due to pulmonary tuberculosis: control with bronchial artery embolization. Radiology. 1996 Sep;200(3):691-4. — View Citation

Ramon P, Wallaert B, Derollez M, D'Odemont JP, Tonnel AB. [Treatment of severe hemoptysis with terlipressin. Study of the efficacy and tolerance of this product]. Rev Mal Respir. 1989;6(4):365-8. French. — View Citation

Rémy J, Arnaud A, Fardou H, Giraud R, Voisin C. Treatment of hemoptysis by embolization of bronchial arteries. Radiology. 1977 Jan;122(1):33-7. — View Citation

Remy J, Lemaitre L, Lafitte JJ, Vilain MO, Saint Michel J, Steenhouwer F. Massive hemoptysis of pulmonary arterial origin: diagnosis and treatment. AJR Am J Roentgenol. 1984 Nov;143(5):963-9. — View Citation

Rémy J, Voisin C, Dupuis C, Beguery P, Tonnel AB, Denies JL, Douay B. [Treatment of hemoptysis by embolization of the systemic circulation]. Ann Radiol (Paris). 1974 Jan-Feb;17(1):5-16. French. — View Citation

Remy-Jardin M, Bouaziz N, Dumont P, Brillet PY, Bruzzi J, Remy J. Bronchial and nonbronchial systemic arteries at multi-detector row CT angiography: comparison with conventional angiography. Radiology. 2004 Dec;233(3):741-9. — View Citation

Revel MP, Fournier LS, Hennebicque AS, Cuenod CA, Meyer G, Reynaud P, Frija G. Can CT replace bronchoscopy in the detection of the site and cause of bleeding in patients with large or massive hemoptysis? AJR Am J Roentgenol. 2002 Nov;179(5):1217-24. — View Citation

Savale L, Parrot A, Khalil A, Antoine M, Théodore J, Carette MF, Mayaud C, Fartoukh M. Cryptogenic hemoptysis: from a benign to a life-threatening pathologic vascular condition. Am J Respir Crit Care Med. 2007 Jun 1;175(11):1181-5. — View Citation

Straus DJ, Yahalom J, Gaynor J, Myers J, Koziner B, Caravelli J, Lee BJ 3rd, Nisce LZ, McCormick B, Bajorunas D, et al. Four cycles of chemotherapy and regional radiation therapy for clinical early-stage and intermediate-stage Hodgkin's disease. Cancer. 1992 Feb 15;69(4):1052-60. — View Citation

Swanson KL, Johnson CM, Prakash UB, McKusick MA, Andrews JC, Stanson AW. Bronchial artery embolization : experience with 54 patients. Chest. 2002 Mar;121(3):789-95. — View Citation

Uflacker R, Kaemmerer A, Picon PD, Rizzon CF, Neves CM, Oliveira ES, Oliveira ME, Azevedo SN, Ossanai R. Bronchial artery embolization in the management of hemoptysis: technical aspects and long-term results. Radiology. 1985 Dec;157(3):637-44. — View Citation

White RI Jr. Bronchial artery embolotherapy for control of acute hemoptysis: analysis of outcome. Chest. 1999 Apr;115(4):912-5. — View Citation

Wong ML, Szkup P, Hopley MJ. Percutaneous embolotherapy for life-threatening hemoptysis. Chest. 2002 Jan;121(1):95-102. — View Citation

Yoon YC, Lee KS, Jeong YJ, Shin SW, Chung MJ, Kwon OJ. Hemoptysis: bronchial and nonbronchial systemic arteries at 16-detector row CT. Radiology. 2005 Jan;234(1):292-8. — View Citation

* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding recurrence rate, after initial therapeutic strategy.	Bleeding recurrence is defined as a volume of expectorated blood of 50 ml or more.	One month
Secondary	Evaluation of the rate of serious adverse events	Evaluation of the rate of serious adverse events, according to the therapeutic strategy during hospitalization and follow-up period	3 months