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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Hemoptysis, Acute Disease

Intervention / Treatment
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* Other: Medicals measures
* Other: bronchial artery embolization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchial Artery Embolization, Non-severe Hemoptysis, Bleeding mild-to-moderate abundance, Volume ranging from 100 ml to 200 ml