Status:
COMPLETED
Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Mallinckrodt
Conditions:
Sickle Cell Disease
Acute Chest Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Acute chest syndrome (ACS) is a frequent and potentially life-threatening pulmonary illness. It is a complication of sickle cell disease and is the leading cause of death from this disease in adults. ...
Detailed Description
Objectives: To compare the outcome and duration of acute chest syndrome (ACS) in patients with sickle cell disease (SCD) treated with iNO to that of similar episodes experienced by patients which rece...
Eligibility Criteria
Inclusion
- Patients with sickle cell disease (Hemoglobin genotypes characterized by standard procedures as homozygous hemoglobin SS, hemoglobin SC, and S beta thalassemia)
- Diagnosis of acute chest syndrome based on the presence of fever, dyspnea or chest pain, associated with new pulmonary infiltrates on chest X-ray
Exclusion
- Patient has been hospitalised \< 14 days ago
- Patients presenting with clinically diagnosed bacterial infections
- Patients who have received an exchange transfusion in the last 30 days or are in a transfusion program.
- Current pregnancy or lactation
- Patient who is currently enrolled in any other investigational drug study
- Previous participation in this study
- Any of the following medical conditions:
- Immediate need of ventilatory support wih orotracheal intubation
- Hemodynamic instability
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00748423
Start Date
December 1 2008
End Date
December 1 2012
Last Update
August 2 2013
Active Locations (1)
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1
Réanimation Médicale, Hôpital A Chenevier-H Mondor
Créteil, France, 94 000