Bronchial Artery Embolization and Medical Measures in Non Severe Acute Hemoptysis of Mild-moderate Abundance (ARTEMHYS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01278199
First received: January 14, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Hemoptysis
Acute Disease
Other: Medicals measures
Other: bronchial artery embolization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Bleeding recurrence rate, after initial therapeutic strategy. [ Time Frame: One month ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Evaluation of the rate of serious adverse events, according to the therapeutic strategy during hospitalization and follow-up period


Estimated Enrollment: 210
Study Start Date: November 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2
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.

Experimental: 1
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278199

Contacts
Contact: Muriel FARTOUKH, MD 33 1 56 01 65 74 muriel.fartoukh@tnn.aphp.fr

Locations
France
Tenon Hospital, AP-HP Recruiting
Paris, France, 75012
Contact: Muriel FARTOUKH, MD    33 1 56 01 65 74    muriel.fartoukh@tnn.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Muriel FARTOUKH, MD Tenon Hospital, AP-HP
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01278199     History of Changes
Other Study ID Numbers: K081202
Study First Received: January 14, 2011
Last Updated: February 26, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Bronchial Artery Embolization
Non-severe Hemoptysis
Bleeding mild-to-moderate abundance
Volume ranging from 100 ml to 200 ml

Additional relevant MeSH terms:
Acute Disease
Hemoptysis
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Hemorrhage
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014