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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05540834




Registration number
NCT05540834
Ethics application status
Date submitted
22/08/2022
Date registered
15/09/2022

Titles & IDs
Public title
Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure
Scientific title
A Phase 2 Safety, Dose-finding and Efficacy Study Evaluating Viscoelastic Testing (VET) Guided Tissue Plasminogen Activator (tPA) Treatment in Critically-ill Pro-thrombotic Acute Respiratory Failure
Secondary ID [1] 0 0
ICU001
Universal Trial Number (UTN)
Trial acronym
VETtiPAT-ARF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Failure 0 0
Hypercoagulability 0 0
Fibrinolysis Shutdown 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Blood 0 0 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alteplase

Experimental: VET guided tPA administration + standard care - Actilyse (tPA) will be administered as a 2-hour bolus then low dose infusion over 24 hours (safety and dose-finding stage) and 72 hours (randomised stage). Regular monitoring of the coagulation status and lysis time using VET will enable increases or decreases/cessation of the dose. Prophylactic low molecular weight heparin will continue throughout.

No intervention: Standard care - Patients will receive standard care for their condition including prophylactic low molecular weight heparin. Coagulation status and lysis time monitoring with VET will occur at the same times as the experimental arm.


Treatment: Drugs: Alteplase
The enzyme tissue plasminogen activator that cleaves plasminogen to form plasmin.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in clot lysis time on viscoelastic testing from baseline and up to 72 hours
Timepoint [1] 0 0
From start to end of alteplase infusion + 1 and up to 72 hours later/ equivalent timeframe in controls
Secondary outcome [1] 0 0
Change in VET coagulation parameters from baseline and up to 72 hours
Timepoint [1] 0 0
From start to end of alteplase infusion + 1 and up to 72 hours later/ equivalent timeframe in controls
Secondary outcome [2] 0 0
Changes in oxygenation
Timepoint [2] 0 0
From start to end of alteplase infusion/ equivalent timeframe in controls
Secondary outcome [3] 0 0
Rate of participants with bleeding events
Timepoint [3] 0 0
From study entry to Day 5
Secondary outcome [4] 0 0
Rate of thromboembolic events
Timepoint [4] 0 0
From study entry to Day 30 or hospital discharge, whichever occurs first
Secondary outcome [5] 0 0
Changes in organ function
Timepoint [5] 0 0
From start to end of alteplase infusion/ equivalent timeframe in controls

Eligibility
Key inclusion criteria
1. Acute respiratory failure of primary pulmonary infectious or extrapulmonary infectious aetiology with severity graded by the arterial oxygen partial pressure to inspired fraction of oxygen ratio (P/F) as per the Berlin definition: acute onset of hypoxemia with an arterial partial pressure of oxygen (PaO2) to inspired fraction of oxygen (FiO2) ratio of less than or equal to 300 mmHg with positive end expiratory pressure (PEEP) of 5 cm of water (H2O) or greater
2. Requiring admission to Intensive Care
3. Aged 18 - 75 years of age
4. Procoagulant profile on ClotPro (TradeMark) fibrinogen (FIB)-test +/- extrinsic coagulation pathway (EX)-test - above normal range for amplitude at 10 minutes (A10) and/or maximal clot firmness (MCF) at 30 minutes run time
5. Lysis Time on ClotPro tissue plasminogen activator (TPA)-test ClotPro equal to or greater than 365 seconds
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Platelet count <150 x 109/L or a reduction in platelet count of 50% or more in the last 24 hours
2. Body weight < 60 kg
3. Structural intracranial disease e.g. arterio-venous malformation or aneurysm
4. Previous intracranial haemorrhage
5. Ischaemic stroke within 3 months
6. Traumatic cardiopulmonary resuscitation
7. Hypoxaemia from traumatic lung injury
8. Active or recent bleeding
9. Recent surgery, trauma or invasive procedure
10. Systolic blood pressure (BP) > 180 mm Hg
11. Diastolic BP > 100 mm Hg
12. Pericarditis or pericardial fluid
13. Diabetic retinopathy
14. Currently menstruating
15. Pregnancy - (beta-human chorionic gonadotropin (HCG) to be performed if of child-bearing age)
16. Liver failure (known severe liver disease or an alanine aminotransferase or an aspartate aminotransferase level that is 5 times the upper limit of normal)
17. Kidney failure (estimated Glomerular Filtration Rate (eGFR =<30 mL/hr or receiving renal replacement therapy)
18. Use of therapeutic anticoagulation or platelet antagonists
19. Not for active treatment
20. Unlikely to survive until the day after tomorrow

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



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District - Liverpool
Recruitment postcode(s) [1] 0 0
1871 - Liverpool

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anders Aneman
Address 0 0
Sydney WAHS
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anders Aneman
Address 0 0
Country 0 0
Phone 0 0
+61 427915693
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05540834