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

NCT01278199 | Completed

• 1 other identifier: K081202
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemoptysis; Acute Disease

Keywords

Bronchial Artery Embolization; Non-severe Hemoptysis; Bleeding mild-to-moderate abundance; Volume ranging from 100 ml to 200 ml

Outcome Measures

Primary Outcomes (1)

• Bleeding recurrence rate, after initial therapeutic strategy.

  Bleeding recurrence is defined as a volume of expectorated blood of 50 ml or more.

  One month

Secondary Outcomes (1)

• Evaluation of the rate of serious adverse events

  3 months

Study Arms (2)

2

OTHER

Medicals measures in the treatment of non-severe acute hemoptysis

Other: Medicals measures

1

EXPERIMENTAL

bronchial artery embolization (BAE)

Other: bronchial artery embolization

Interventions

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.

2

bronchial artery embolization OTHER

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-severe acute hemoptysis (mild-to-moderate abundance and no criteria of severity).
• Age \> 18 years
• Patients with social insurance

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Tenon Hospital, AP-HP

Paris, 75012, France

Location

Related Publications (41)

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MeSH Terms

Conditions

Hemoptysis; Acute Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Muriel FARTOUKH, MD

  Tenon Hospital, AP-HP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: November 1, 2011
• Primary Completion: December 27, 2016
• Study Completion: February 27, 2017
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

FR (1)