Nebulized Heparin for COVID19-associated Acute Respiratory Failure
- Registration Number
- NCT04842292
- Lead Sponsor
- Brittany Bissell
- Brief Summary
The objective of the current study is to investigate the utilization of nebulized heparin to circumvent pathologic changes in COVID-19 and prevent harmful effects possible with systemic anticoagulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
Inclusion Criteria
Patients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS (paO2/FiO2 ratio =300) within 48 hours
Exclusion Criteria
- Allergy to heparin
- Any history of heparin-induced thrombocytopenia
- High risk of bleeding (platelet count < 50,000/µL or international normalized ratio > 1.5)
- Patients with known bleeding disorders (i.e. hemophilia or von Willebrand Disease)
- Active bleeding
- Pulmonary bleeding during this hospital admission (Pulmonary bleeding is frank bleeding in the lungs, trachea or bronchi with repeated hemoptysis, or requiring repeated suctioning, and temporally associated with acute deterioration in respiratory status)
- Neurosurgical procedures during this hospital admission or such procedures are planned
- Epidural catheter in place
- Any history of intracranial, spinal or epidural hemorrhage
- Tracheostomy in place
- Cervical spinal cord injury associated with reduced long-term ability to breathe independently
- Spinal or peripheral nerve disease with a likely prolonged reduction in the ability to breathe independently
- Receiving extra-corporeal membrane oxygenation or continuous renal replacement therapy
- Usually treated with hemodialysis or peritoneal dialysis for end-stage renal failure
- Death is deemed imminent or inevitable or there is an underlying disease with a life expectancy of fewer than 90 days
- Pregnant or might be pregnant.
- Objection from the treating clinician
- Consent refused by the patient or substitute decision maker.
- History of thrombosis (VTE or cardiovascular event)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nebulized placebo Placebo Sodium chloride 0.9% 5 mL inhalation every 6 hours Nebulized heparin Heparin Nebulized heparin 25,000 units in 3 mL inhalation every 6 hours
- Primary Outcome Measures
Name Time Method Mean PaO2/FiO2 Ratio Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first
- Secondary Outcome Measures
Name Time Method Clinically Significant Bleeding Up to discharge or 3 months following enrollment, whichever occurs first Incidence of Venous Thromboembolism Up to discharge or 3 months following enrollment, whichever occurs first
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie nebulized heparin's anticoagulant effects in acute respiratory distress syndrome (ARDS)?
How does nebulized heparin compare to systemic anticoagulation in preventing microthrombosis in severe COVID-19 patients?
Are there specific biomarkers that predict response to nebulized heparin in SARS-CoV-2-induced pulmonary inflammation?
What adverse events are associated with nebulized heparin administration in mechanically ventilated ICU patients?
How do nebulized anticoagulants like heparin compare to inhaled corticosteroids in managing viral pneumonia complications?
Trial Locations
- Locations (1)
UK Healthcare
🇺🇸Lexington, Kentucky, United States
UK Healthcare🇺🇸Lexington, Kentucky, United States