Role of Heparin inhalation in reducing the duration the patient is breathing with the help of a ventilator
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J22- Unspecified acute lower respiratory infection
- Registration Number
- CTRI/2020/11/029175
- Lead Sponsor
- AIIMS Patna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Confirmed COVID-19, Endotracheal tube in place, Intubated the day before or same day, PaO2 to FIO2 ratio less than or equal to 300 while intubated, Acute opacities not fully explained by effusions, lobar/lung collapse and nodules, affecting at least one lung quadrant on chest X-ray or CT, Currently in the ICU or scheduled for transfer to the ICU.
Enrolled in another clinical trial that is unapproved for co-enrolment, Heparin allergy or HIT, APTT > 120 seconds and this is not due to anticoagulant therapy, Platelet count < 20 x 109 per L, Pulmonary bleeding, which is frank bleeding in the trachea, bronchi or lungs with, Repeated haemoptysis or requiring repeated suctioning, Uncontrolled bleeding, Pregnant or might be pregnant, Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain-Barre syndrome, Usually receives home oxygen, Death is imminent or inevitable within 24 hours
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the time to separation from mechanical ventilation (duration of mechanical ventilation) upto day 28Timepoint: The primary outcome is the time to separation from mechanical ventilation (duration of mechanical ventilation) upto day 28
- Secondary Outcome Measures
Name Time Method ï??Change in oxygenation index, driving pressure and ventilatory ratio at day 2 <br/ ><br>ï??Change in white cell count, platelet count, C-reactive protein, D-dimer and INR to day 10 <br/ ><br>ï??Number tracheotomised to day 28 <br/ ><br>ï??Time to separation from the ICU to day 28, among survivors <br/ ><br>ï??Survival to day 28; Survival to day 60; and Survival to hospital discharge, censored at day60 <br/ ><br>ï??Number residing at home or in a community setting at day 60, among survivors <br/ ><br>Timepoint: the time to separation from mechanical ventilation (duration of mechanical ventilation) upto day 10 or 28 or 60 days as applicable.