Acute Disease, Hemoptysis
Conditions
Keywords
Bronchial Artery Embolization, Non-severe Hemoptysis, Bleeding mild-to-moderate abundance, Volume ranging from 100 ml to 200 ml
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.
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).
Interventions
OTHERMedicals 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.
OTHERbronchial artery embolization
The bronchial artery embolization is practised within 48 hours which follow the hospital admission for non-severe acute hemoptysis.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed