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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01278199

Collaborator

(none)

Enrollment

Location

Arms

63.9

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hemoptysis Acute Disease	Other: Medicals measures Other: bronchial artery embolization	N/A

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Dec 27, 2016

Actual Study Completion Date :

Feb 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 2 Medicals measures in the treatment of non-severe acute hemoptysis	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.
Experimental: 1 bronchial artery embolization (BAE)	Other: bronchial artery embolization The bronchial artery embolization is practised within 48 hours which follow the hospital admission for non-severe acute hemoptysis.

Arm

Intervention/Treatment

Other: 2

Medicals measures in the treatment of non-severe acute hemoptysis

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.

Experimental: 1

bronchial artery embolization (BAE)

Other: bronchial artery embolization

The bronchial artery embolization is practised within 48 hours which follow the hospital admission for non-severe acute hemoptysis.

Outcome Measures

Primary Outcome Measures

Bleeding recurrence rate, after initial therapeutic strategy. [One month]
Bleeding recurrence is defined as a volume of expectorated blood of 50 ml or more.

Secondary Outcome Measures

Evaluation of the rate of serious adverse events [3 months]
Evaluation of the rate of serious adverse events, according to the therapeutic strategy during hospitalization and follow-up period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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