Status:
COMPLETED
Nebulised Heparin to Reduce COVID-19 Induced Acute Lung Injury
Lead Sponsor:
University College Hospital Galway
Conditions:
Covid19
ARDS, Human
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The investigators present a randomised open label phase Ib/IIa trial of nebulised unfractionated heparin to evaluate the effect of nebulised unfractionated heparin on the procoagulant response in ICU ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- To be eligible, a patient must satisfy all these inclusion criteria:
- Confirmed or suspected COVID-19. Note, if 'suspected', results must be pending or testing intended
- Ability to obtain informed consent/assent to participate in study
- Age 18 years or older
- Requiring high flow nasal oxygen or positive pressure ventilator support or invasive mechanical ventilation for a time period of no greater than 48 hours
- D-dimers \> 200 ng/ml
- PaO2 to FIO2 ratio less than or equal to 300
- Acute opacities on chest imaging affecting at least one lung quadrant. Note 'Acute opacities' do not include effusions, lobar/lung collapse or nodules
- Currently in a higher level of care area designated for inpatient care of patients where therapies including non-positive pressure ventilatory support can be provided.
- Exclusion criteria
- To be eligible, a patient must have none of these exclusion criteria:
- Enrolled in another clinical trial that is unapproved for co-enrolment
- Heparin allergy or heparin-induced thrombocytopaenia
- APTT \> 100 seconds
- Platelet count \< 50 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 suspected pregnancy (Urine or serum HCG will be recorded)
- Receiving or about to commence ECMO or HFOV
- 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
- Dependent on others for personal care due to physical or cognitive decline (pre-morbid status)
- Death is imminent or inevitable within 24 hours
- The clinical team would not be able to set up the study nebuliser and ventilator circuit as required including with active humidification
- Clinician objection.
- The use or anticipated use of nebulised tobramycin during this clinical episode
- Any other specific contraindication to anticoagulation including prophylactic anticoagulation not otherwise listed here
- Relapse in clinical condition in patient that had fully weaned from advanced respiratory support
- Any systemic anticoagulation other than prophylactic anticoagulation
Exclusion
Key Trial Info
Start Date :
December 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04511923
Start Date
December 23 2020
End Date
February 28 2022
Last Update
July 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Galway
Galway, Ireland