Bronchial Artery Embolization and Medical Measures in Non Severe Acute Hemoptysis of Mild-moderate Abundance
Keywords
Abstract
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).
Dates
| Last Verified: | 02/28/2017 |
| First Submitted: | 01/13/2011 |
| Estimated Enrollment Submitted: | 01/13/2011 |
| First Posted: | 01/16/2011 |
| Last Update Submitted: | 03/20/2017 |
| Last Update Posted: | 03/21/2017 |
| Actual Study Start Date: | 10/31/2011 |
| Estimated Primary Completion Date: | 12/26/2016 |
| Estimated Study Completion Date: | 02/26/2017 |
Condition or disease
Intervention/treatment
Other: 2
Other: 1
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Other: 2 Medicals measures in the treatment of non-severe acute hemoptysis | Other: 2 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. |
| Experimental: 1 bronchial artery embolization (BAE) | Other: 1 The bronchial artery embolization is practised within 48 hours which follow the hospital admission for non-severe acute hemoptysis. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Bleeding recurrence rate, after initial therapeutic strategy. [One month]
Secondary Outcome Measures
1. Evaluation of the rate of serious adverse events [3 months]
