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

March 21, 2017 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Tenon Hospital, AP-HP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Muriel FARTOUKH, MD, Tenon Hospital, AP-HP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2011

Primary Completion (ACTUAL)

December 27, 2016

Study Completion (ACTUAL)

February 27, 2017

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (ESTIMATE)

January 17, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K081202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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