Nebulised heparin for lung injury

A multi-centre randomised, placebo controlled trial of nebulised heparin in patients with or at risk of developing Acute Respiratory Distress Syndrome, to determine if nebulised heparin improves long term physical function.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000418875

Acronym

CHARLI - Can Heparin Administration Reduce Lung Injury

Enrollment

256

Registered

2012-04-13

Start date

2012-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will test the primary hypothesis that nebulised heparin ameliorates the severity of lung damage resulting in faster recovery of physical function in critically ill patients with, or at risk of developing, ARDS. Other aims of the study include determining if nebulised heparin improves quality of life, shortens intensive care and hospital lengths of stay and is cost-effective.

Interventions

Randomised to nebulised liquid heparin (25,000 IU in 5 ml) versus placebo (5 ml of nebulised liquid 0.9% sodium chloride). The study medication is given every six hours for up to 10 days while the patient requires ventilation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Receiving ventilation via an endotracheal tube Started ventilation via an endotracheal tube yesterday or today Expected to require invasive ventilation for at least all of today and all of tomorrow PaO2 to FiO2 ratio less than 300 Active ventilator circuit humidification

Exclusion criteria

Allergy to heparin; any history of heparin induced thrombocytopenia Platelet count less than 50 x 109/L; activated partial thromboplastin time (APTT) is prolonged to greater than 80 seconds and this is not due to anticoagulant therapy Uncontrolled bleeding; pulmonary bleeding during this hospital admission; any history of intracranial, spinal or epidural haemorrhage Neurosurgical procedures during this hospital admission or such procedures are planned; an epidural catheter is in place Hepatic encephalopathy or any history of gastrointestinal bleeding due to portal hypertension or biopsy proven cirrhosis with documented portal hypertension Tracheostomy in place; usually receives home oxygen; usually receives any type of assisted ventilation at home e.g. continuous positive airway pressure for obstructive sleep apnoea 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 e.g. Guillain-Barre syndrome, motor neurone disease Receiving high frequency oscillation ventilation or extra corporeal membrane oxygenation Pregnant or might be pregnant Treatment limits restrict the provision of renal replacement therapy, inotropes, vasopressors or prolonged invasive ventilation; usually treated with haemodialysis or peritoneal dialysis for end-stage renal failure; dementia; death is deemed imminent or inevitable or there is underlying disease with a life expectancy of less than 90 days

Outcome results