ANZCTR - Registration

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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]

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.

Condition category

Condition code

Respiratory

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]

Prevention

Comparator / control treatment

placebo is 5 ml of nebulised 0.9% sodium chloride

Control group

Placebo

Outcomes

Primary outcome [1]

Physical function assessed using the physical function component of the SF-36 health survey.

Timepoint [1]

Assessed 60 days after randomisation

Secondary outcome [1]

mortality assessed by review of medical records and contact with patient or next of kin

Timepoint [1]

Intensive care discharge, hospital discharge and 60-days after randomisation

Secondary outcome [2]

Quality of life assessed by contact with patient or next of kin and undertaking EQ5D survey

Timepoint [2]

assessed 60 days and six months after randomisation

Secondary outcome [3]

Mechanical ventilation-free days assessed by review of medical records

Timepoint [3]

assessed 28 days after randomisation

Secondary outcome [4]

Change in Murray Lung Injury Score assessed by review of medical records

Timepoint [4]

assessed 5 days after randomisation

Secondary outcome [5]

Development of ALI or ARDS assessed by review of medical records

Timepoint [5]

assessed 5 days after randomisation

Secondary outcome [6]

Lung rescue therapies assessed by review of medical records

Timepoint [6]

assessed 28 days after randomisation

Secondary outcome [7]

Healthcare utilisation assessed by review of medical records

Timepoint [7]

assessed 6 months after randomisation

Secondary outcome [8]

Change in plasma thrombin time, D-Dimer, antithrombin thrombin levels and serum cytokines assessed by blood analysis

Timepoint [8]

assessed 3 days after randomisation

Secondary outcome [9]

Hospital stay duration assessed by review of medical records

Timepoint [9]

assessed at hospital discharge

Secondary outcome [10]

ICU stay duration assessed by review of medical records

Timepoint [10]

assessed 28 days after randomisation

Secondary outcome [11]

Major bleeding or other complications assessed by review of medical records

Timepoint [11]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/08/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

256

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St.Vincents Hospital/Institute

Address [1]

Fitzroy, Melbourne, Victoria, Australia
PO Box 2900, 3065

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St.Vincent's Hospital

Ethics committee address [1]

41 Victoria Pde, Fitzroy, Melbourne, PO Box 2900, 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

16/03/2012

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Barry Dixon

Address

St.Vincents Hospital Intensive Care, Victoria
Fitzroy, PO Box 2900, 3065

Country

Australia

Phone

610392884488

Fax

610392884487

[email protected]

Contact person for scientific queries

Name

Barry Dixon

Address

St.Vincents Hospital Intensive Care, Victoria
Fitzroy, PO Box 2900, 3065

Country

Australia

Phone

610392884488

Fax

610392884487

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Mechanical ventilation in intensive care for 48 h ... [More Details]
Study results article	Yes		Lancet Resp Medicine VOLUME 9, ISSUE 4, P360-372,... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Future therapies for ARDS.	2015	https://dx.doi.org/10.1007/s00134-014-3578-z
Embase	Nebulised heparin for patients with or at risk of acute respiratory distress syndrome: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial.	2021	https://dx.doi.org/10.1016/S2213-2600%2820%2930470-7

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically