An interventional study of Medicals measures and bronchial artery embolization in Hemoptysis and Acute Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
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).
37 studies on the registry are indexed under Hemoptysis; 6 are open to participants now.
This study's enrollment of 73 is close to the median of 73 across 20 interventional studies indexed under Hemoptysis.
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Exclusion Criteria:
Medicals measures in the treatment of non-severe acute hemoptysis
Other: Medicals measures
bronchial artery embolization (BAE)
Other: bronchial artery embolization
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.
The bronchial artery embolization is practised within 48 hours which follow the hospital admission for non-severe acute hemoptysis.
Bleeding recurrence rate, after initial therapeutic strategy.
Bleeding recurrence is defined as a volume of expectorated blood of 50 ml or more.
Time frame: One month
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
Time frame: 3 months
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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