CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 73 enrolled
Drug / intervention
Medicals measures +1 moreother
Likely dose
Not stated in record
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Search/NCT01278199
NCT01278199N/ACompleted

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

Assistance Publique - Hôpitaux de Paris·interventional·Posted Jan 17, 2011·Updated Mar 22, 2017

In Brief

A clinical study evaluating Medicals measures and bronchial artery embolization for Hemoptysis and Acute Disease. Completed, enrolled 73 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 17, 2011
Enrollment StartNov 1, 2011
Primary CompletionDec 27, 2016
Study CompletionFeb 27, 2017
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 15.5 years ago

Interventions

Medicals measuresother

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 embolizationother

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