Bronchial Artery Embolization and Medical Measures in Non Severe Acute Hemoptysis of Mild-moderate Abundance (ARTEMHYS)
Primary Purpose
Hemoptysis, Acute Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Medicals measures
bronchial artery embolization
Sponsored by
About this trial
This is an interventional other trial for Hemoptysis focused on measuring Bronchial Artery Embolization, Non-severe Hemoptysis, Bleeding mild-to-moderate abundance, Volume ranging from 100 ml to 200 ml
Eligibility 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
Sites / Locations
- Tenon Hospital, AP-HP
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
2
1
Arm Description
Medicals measures in the treatment of non-severe acute hemoptysis
bronchial artery embolization (BAE)
Outcomes
Primary Outcome Measures
Bleeding recurrence rate, after initial therapeutic strategy.
Bleeding recurrence is defined as a volume of expectorated blood of 50 ml or more.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01278199
First Posted
January 14, 2011
Last Updated
March 21, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01278199
Brief Title
Bronchial Artery Embolization and Medical Measures in Non Severe Acute Hemoptysis of Mild-moderate Abundance
Acronym
ARTEMHYS
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
December 27, 2016 (Actual)
Study Completion Date
February 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemoptysis, Acute Disease
Keywords
Bronchial Artery Embolization, Non-severe Hemoptysis, Bleeding mild-to-moderate abundance, Volume ranging from 100 ml to 200 ml
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Other
Arm Description
Medicals measures in the treatment of non-severe acute hemoptysis
Arm Title
1
Arm Type
Experimental
Arm Description
bronchial artery embolization (BAE)
Intervention Type
Other
Intervention Name(s)
Medicals measures
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
bronchial artery embolization
Intervention Description
The bronchial artery embolization is practised within 48 hours which follow the hospital admission for non-severe acute hemoptysis.
Primary Outcome Measure Information:
Title
Bleeding recurrence rate, after initial therapeutic strategy.
Description
Bleeding recurrence is defined as a volume of expectorated blood of 50 ml or more.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Evaluation of the rate of serious adverse events
Description
Evaluation of the rate of serious adverse events, according to the therapeutic strategy during hospitalization and follow-up period
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muriel FARTOUKH, MD
Organizational Affiliation
Tenon Hospital, AP-HP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tenon Hospital, AP-HP
City
Paris
ZIP/Postal Code
75012
Country
France
12. IPD Sharing Statement
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PubMed Identifier
10208199
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Bronchial Artery Embolization and Medical Measures in Non Severe Acute Hemoptysis of Mild-moderate Abundance
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