Pulmonary Embolism Clinical Trial
Official title:
Inhaled Nitric Oxide in Pulmonary Embolism, a Randomized, Double-Blind Placebo-Controlled Study
Verified date | June 2010 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Agency for Health and Food Safety |
Study type | Interventional |
The purpose of the study is to determine if inhaled nitric oxide, a potent and selective pulmonary vasodilator, is beneficial in patients with acute pulmonary embolism causing increased right ventricular afterload.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with acute pulmonary embolism within 24 hours after onset of symptoms. - Patients with hypoxaemia not present before pulmonary embolism and acute right ventricular dysfunction. Exclusion Criteria: - Age < 18 years. - Chronic lung disease, left heart failure, suspected or documented intracranial bleeding. - Pregnancy, Methaemoglobinaemia. - Patients who previously needed thrombolysis or surgical embolectomy. - Negative D-Dimer test. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | University of Emergency Medicine, Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Capellier G, Jacques T, Balvay P, Blasco G, Belle E, Barale F. Inhaled nitric oxide in patients with pulmonary embolism. Intensive Care Med. 1997 Oct;23(10):1089-92. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | right ventricular size and arterial oxygenation | 2 hours | ||
Secondary | blood pressure, central venous pressure, right ventricular function, pulmonary artery pressure | 2 hours |
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