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Trial registered on ANZCTR


Registration number
ACTRN12612000418875
Ethics application status
Approved
Date submitted
6/04/2012
Date registered
13/04/2012
Date last updated
16/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Nebulised heparin for lung injury
Scientific title
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.
Secondary ID [1] 280285 0
nil
Universal Trial Number (UTN)
U1111-1129-8276
Trial acronym
CHARLI - Can Heparin Administration Reduce Lung Injury
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with or at risk of developing Acute Respiratory Distress Syndrome. 286243 0
Condition category
Condition code
Respiratory 286458 286458 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284638 0
Prevention
Comparator / control treatment
placebo is 5 ml of nebulised 0.9% sodium chloride
Control group
Placebo

Outcomes
Primary outcome [1] 286905 0
Physical function assessed using the physical function component of the SF-36 health survey.
Timepoint [1] 286905 0
Assessed 60 days after randomisation
Secondary outcome [1] 296958 0
mortality assessed by review of medical records and contact with patient or next of kin
Timepoint [1] 296958 0
Intensive care discharge, hospital discharge and 60-days after randomisation
Secondary outcome [2] 296959 0
Quality of life assessed by contact with patient or next of kin and undertaking EQ5D survey
Timepoint [2] 296959 0
assessed 60 days and six months after randomisation
Secondary outcome [3] 296960 0
Mechanical ventilation-free days assessed by review of medical records
Timepoint [3] 296960 0
assessed 28 days after randomisation
Secondary outcome [4] 296961 0
Change in Murray Lung Injury Score assessed by review of medical records
Timepoint [4] 296961 0
assessed 5 days after randomisation
Secondary outcome [5] 296962 0
Development of ALI or ARDS assessed by review of medical records
Timepoint [5] 296962 0
assessed 5 days after randomisation
Secondary outcome [6] 296963 0
Lung rescue therapies assessed by review of medical records
Timepoint [6] 296963 0
assessed 28 days after randomisation
Secondary outcome [7] 296964 0
Healthcare utilisation assessed by review of medical records
Timepoint [7] 296964 0
assessed 6 months after randomisation
Secondary outcome [8] 296965 0
Change in plasma thrombin time, D-Dimer, antithrombin thrombin levels and serum cytokines assessed by blood analysis
Timepoint [8] 296965 0
assessed 3 days after randomisation
Secondary outcome [9] 296966 0
Hospital stay duration assessed by review of medical records
Timepoint [9] 296966 0
assessed at hospital discharge
Secondary outcome [10] 296967 0
ICU stay duration assessed by review of medical records
Timepoint [10] 296967 0
assessed 28 days after randomisation
Secondary outcome [11] 297050 0
Major bleeding or other complications assessed by review of medical records
Timepoint [11] 297050 0
assessed 28 days after randomisation

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be maintained throughout by the use of central, secure web randomisation process hosted at the University of Sydney’s Northern Clinical School Intensive Care Research Unit (NCS ICRU).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
SAS software statistical system, stratified by center. Blocks of variable size and a random seed will be used to ensure allocation concealment cannot be violated by deciphering the sequence near the end of each block. To further protect from deciphering, block size will not be revealed to site Investigators.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285053 0
Hospital
Name [1] 285053 0
St.Vincents Hospital/Institute
Address [1] 285053 0
Fitzroy, Melbourne, Victoria, Australia
PO Box 2900, 3065
Country [1] 285053 0
Australia
Primary sponsor type
Hospital
Name
St.Vincents Hospital/Institute
Address
Fitzroy, Melbourne, Victoria, Australia, PO Box 2900, 3065
Country
Australia
Secondary sponsor category [1] 283917 0
None
Name [1] 283917 0
Address [1] 283917 0
Country [1] 283917 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287058 0
St.Vincent's Hospital
Ethics committee address [1] 287058 0
41 Victoria Pde, Fitzroy, Melbourne, PO Box 2900, 3065
Ethics committee country [1] 287058 0
Australia
Date submitted for ethics approval [1] 287058 0
Approval date [1] 287058 0
16/03/2012
Ethics approval number [1] 287058 0
12/SVHM/6

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34032 0
Address 34032 0
Country 34032 0
Phone 34032 0
Fax 34032 0
Email 34032 0
Contact person for public queries
Name 17279 0
Barry Dixon
Address 17279 0
St.Vincents Hospital Intensive Care, Victoria
Fitzroy, PO Box 2900, 3065
Country 17279 0
Australia
Phone 17279 0
610392884488
Fax 17279 0
610392884487
Email 17279 0
barry.dixon@svhm.org.au
Contact person for scientific queries
Name 8207 0
Barry Dixon
Address 8207 0
St.Vincents Hospital Intensive Care, Victoria
Fitzroy, PO Box 2900, 3065
Country 8207 0
Australia
Phone 8207 0
610392884488
Fax 8207 0
610392884487
Email 8207 0
barry.dixon@svhm.org.au

No information has been provided regarding IPD availability
How or where can supporting documents be obtained?
Type [1] 2822 0
Study protocol
Citation [1] 2822 0
Link [1] 2822 0
Email [1] 2822 0
Other [1] 2822 0
Attachment [1] 2822 0
Type [2] 2823 0
Clinical study report
Citation [2] 2823 0
Link [2] 2823 0
Email [2] 2823 0
Other [2] 2823 0
Attachment [2] 2823 0
Type [3] 2824 0
Ethical approval
Citation [3] 2824 0
Link [3] 2824 0
Email [3] 2824 0
Other [3] 2824 0
Attachment [3] 2824 0
Type [4] 2825 0
Analytic code
Citation [4] 2825 0
Link [4] 2825 0
Email [4] 2825 0
Other [4] 2825 0
Attachment [4] 2825 0
Type [5] 2826 0
Informed consent form
Citation [5] 2826 0
Link [5] 2826 0
Email [5] 2826 0
Other [5] 2826 0
Attachment [5] 2826 0
Type [6] 2827 0
Statistical analysis plan
Citation [6] 2827 0
Link [6] 2827 0
Email [6] 2827 0
Other [6] 2827 0
Attachment [6] 2827 0
Summary results
No Results