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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Fibrinolytic treatment of acute respiratory failure due to inflammatory lung injury
Scientific title
Fibrinolytic treatment of acute respiratory failure due to inflammatory lung injury to assess improvement in alveolar dead space and right ventricular function
Secondary ID [1] 253027 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute respiratory failure due to inflammatory lung injury 258588 0
Condition category
Condition code
Respiratory 258725 258725 0 0
Other respiratory disorders / diseases

Study type
Description of intervention(s) / exposure
Administration of tissue plasminogen activator (t-PA) on one occasion.

Dose escalation study

The first 4 patients will receive

1. 10 mg bolus and 10 mg over 30 min.

The second 4 patients will receive

2. 10 mg bolus and 20 mg over 30 min.

The final 4 patients will receive

3. 10 mg bolus and 40 mg over 30 min.
Intervention code [1] 257553 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group

Primary outcome [1] 259592 0
Phase 1 study

Alveolar dead space will be assessed using an expired breath carbon dioxide analyser
Timepoint [1] 259592 0
baseline and at 1 and 4 hours post t-pa
Primary outcome [2] 259593 0
pulmonary artery pressure and cardiac function will be assessed using echocardiology
Timepoint [2] 259593 0
baseline and at 1 and 4 hours post t-pa
Primary outcome [3] 259594 0
safety (bleeding) will be assessed by monitoring of the patient in the Intensive Care Unit for fall in Haemoglobin levels or clinical evidence of bleeding
Timepoint [3] 259594 0
in 24 hours following the t-pa
Secondary outcome [1] 266224 0
urinary albumin creatinine ratio will be assessed by analysing albumin and creatinine levels in the urine
Timepoint [1] 266224 0
baseline and at 1 and 4 hours post t-pa

Key inclusion criteria
Patients with acute respiratory failure due to an acute inflammatory insult.
Requiring positive pressure ventilation via an endo-tracheal tube.
Impaired oxygenation - arterial partial pressure of oxygen to inspire fraction of oxygen ratio (P/F) <300 mmHg.
At least one quadrant of pulmonary infiltrate present on CXR.
Enrolled within 24 hrs of developing all of these criteria.
Minimum age
15 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Known hypersensitivity to alteplase (t-PA)
Aspirin in the last week
Any therapeutic anti-coagulant therapy
Significant bleeding disorder within the past six months
Any history of brain or spinal injury including trauma, stroke, transient ischaemic attack, neoplasm, surgery, infection, aneurysm or intracranial bleed.
Uncontrolled hypertension, systolic blood pressure (BP) >185 mmHg or diastolic BP >110 mmHg.
Recent (within ten days) prolonged or traumatic cardiopulmonary resuscitation (> 2 minutes), obstetric delivery, organ biopsy, puncture of non-compressible blood vessel (e.g. subclavian vein), major surgery or significant trauma.
Documented ulcerative gastrointestinal disease during the last three months.
Arterial aneurysms, arterial/venous malformations.
Neoplasm with increased bleeding risk.
Bacterial endocarditis, pericarditis.
Acute pancreatitis.
Severe hepatic disease/ dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) or active hepatitis.
Age <18 or > 75
Pulmonary haemorrhage in previous 12 months
Major surgery planned over the next 2 days
Diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions.
Unlikely to survive 24 hours
Platelet count below 80,000/mm3

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
not applicable
Phase 1
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 258004 0
Self funded/Unfunded
Name [1] 258004 0
Barry Dixon
Address [1] 258004 0
St Vincent's Hospital Fitzroy, Victoria, 3065
Country [1] 258004 0
Primary sponsor type
St Vincent's Hospital
Victoria Pde, Fitzroy, Victoria, 3065
Secondary sponsor category [1] 257199 0
Name [1] 257199 0
Address [1] 257199 0
Country [1] 257199 0

Ethics approval
Ethics application status
Ethics committee name [1] 259999 0
St Vincent's Hospital Fitzroy, Victoria, 3065
Ethics committee address [1] 259999 0
41 Victoria Pde, Fitzroy, Victoria, 3065
Ethics committee country [1] 259999 0
Date submitted for ethics approval [1] 259999 0
Approval date [1] 259999 0
Ethics approval number [1] 259999 0

Brief summary
Inflammatory insults including pneumonia, sepsis, aspiration, trauma, prolonged hypotension, cardiac surgery and pancreatitis can cause lung damage. One mechanism by which inflammation mediates lung injury is through deposition of fibrin in the pulmonary microcirculation. This study will investigate if limiting fibrin deposition through administration of tissue plasminogen activator reduces lung damage.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 31873 0
Address 31873 0
Country 31873 0
Phone 31873 0
Fax 31873 0
Email 31873 0
Contact person for public queries
Name 15120 0
Barry Dixon
Address 15120 0
ICU St.Vincent's Hospital 41 Victoria Pde, Melbourne, Victoria, 3065
Country 15120 0
Phone 15120 0
61 0439618815
Fax 15120 0
Email 15120 0
Contact person for scientific queries
Name 6048 0
Barry Dixon
Address 6048 0
ICU St.Vincent's Hospital 41 Victoria Pde, Fitzroy, Melbourne, Victoria, 3065
Country 6048 0
Phone 6048 0
61 0439618815
Fax 6048 0
Email 6048 0

No information has been provided regarding IPD availability
Summary results
No Results