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NCT Number: NCT01278199

Bronchial Artery Embolization and Medical Measures in Non Severe Acute Hemoptysis of Mild-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.

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Key information

Conditions

Hemoptysis Acute Disease Disease Attributes Hemorrhage Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tenon Hospital, AP-HP

Paris, 75012, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medicals measures

Other

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

Other

The bronchial artery embolization is practised within 48 hours which follow the hospital admission for non-severe acute hemoptysis.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: ARTEMHYS

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Jan 17, 2011
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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