Bronchial Artery Embolization and Medical Measures in Non Severe Acute Hemoptysis of Mild-moderate Abundance (ARTEMHYS)
|ClinicalTrials.gov Identifier: NCT01278199|
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hemoptysis Acute Disease||Other: Medicals measures Other: bronchial artery embolization||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||November 2011|
|Actual Primary Completion Date :||December 27, 2016|
|Actual Study Completion Date :||February 27, 2017|
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.
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.
- Bleeding recurrence rate, after initial therapeutic strategy. [ Time Frame: One month ]Bleeding recurrence is defined as a volume of expectorated blood of 50 ml or more.
- Evaluation of the rate of serious adverse events [ Time Frame: 3 months ]Evaluation of the rate of serious adverse events, according to the therapeutic strategy during hospitalization and follow-up period
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278199
|Tenon Hospital, AP-HP|
|Paris, France, 75012|
|Principal Investigator:||Muriel FARTOUKH, MD||Tenon Hospital, AP-HP|