Bronchial Artery Embolization and Medical Measures in Non Severe Acute Hemoptysis of Mild-moderate Abundance
NCT ID: NCT01278199
Last Updated: 2017-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2011-11-30
2017-02-27
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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2
Medicals measures in the treatment of non-severe acute hemoptysis
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.
1
bronchial artery embolization (BAE)
bronchial artery embolization
The bronchial artery embolization is practised within 48 hours which follow the hospital admission for non-severe acute hemoptysis.
Interventions
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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
The bronchial artery embolization is practised within 48 hours which follow the hospital admission for non-severe acute hemoptysis.
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Patients with social insurance
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Muriel FARTOUKH, MD
Role: PRINCIPAL_INVESTIGATOR
Tenon Hospital, AP-HP
Locations
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Tenon Hospital, AP-HP
Paris, , France
Countries
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References
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Other Identifiers
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K081202
Identifier Type: -
Identifier Source: org_study_id
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