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Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure
Patients with coronavirus disease (COVID) and non-COVID acute respiratory failure (ARF) may be at an increased risk of thrombosis due to increased clot formation and decreased clot lysis. This two stage study aims to utilise bedside coagulation technology to detect patients at increased risk and guide tPA treatment to maximise efficacy and safety through a personalised approach.
Study details:
Acute respiratory failure (ARF) due to COVID is associated with an increased risk of thrombosis causing death. Therapeutic heparin administration was not beneficial in the critically ill. In non-COVID ARF patients, the presence of multiple pulmonary vessel filling defects associated with the severity of disease and patient outcome, and resolved following the administration of the fibrinolytics, streptokinase and urokinase.
An early phase I study reported improved oxygenation in patients with severe ARF following administration of plasminogen activators. The rationale for fibrinolytics in ARF has been published previously and is supported by meta-analysis of preclinical studies. In both non-COVID and COVID associated ARF, defective fibrinolysis has been demonstrated.
Standard coagulation tests cannot identify a hypercoagulable state nor assess fibrinolysis whereas viscoelastic testing (VET), a rapid, point-of-care device commonly used in Intensive Care, is able to detect these disorders. Numerous studies have demonstrated that VET is sufficiently sensitive to detect the coagulopathies associated with ARF, with several parameters associating with disease severity. The VETtiPAT ARF trial uses VET to identify ARF patients with a procoagulant and hypofibrinolytic phenotype, then to guide tPA (Alteplase) administration thus maximising efficacy and safety through a personalised precision medicine approach.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-05-18
Primary completion: 2026-05-01
Study completion finish: 2026-12-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05540834
Intervention or treatment
DRUG: Alteplase
Conditions
- • Acute Respiratory Failure
- • Hypercoagulability
- • Fibrinolysis Shutdown
Find a site
Closest Location:
Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District
Research sites nearby
Select from list below to view details:
Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District
Liverpool, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: VET guided tPA administration + standard care
| DRUG: Alteplase
|
NO_INTERVENTION: Standard care
| Not specified |
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Change in clot lysis time on viscoelastic testing from baseline and up to 72 hours | The impact of alteplase administration on the clot lysis time (in seconds) measured by the TPA-test using the ClotPro at the bedside | From start to end of alteplase infusion + 1 and up to 72 hours later/ equivalent timeframe in controls |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Change in VET coagulation parameters from baseline and up to 72 hours | The impact of alteplase administration on clot formation related to fibrinogen and the extrinsic pathway (maximum clot firmness (MCF) / amplitude at 10 minutes (A10) in millimeters) measured by the FIB-test and EX-test using the ClotPro at the bedside | From start to end of alteplase infusion + 1 and up to 72 hours later/ equivalent timeframe in controls |
Changes in oxygenation | Arterial partial pressure of oxygen to inspired fraction of oxygen (P/F) ratio | From start to end of alteplase infusion/ equivalent timeframe in controls |
Rate of participants with bleeding events | Any bleeding events Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater | From study entry to Day 5 |
Rate of thromboembolic events | Any thromboembolic event | From study entry to Day 30 or hospital discharge, whichever occurs first |
Changes in organ function | Sequential Organ Failure Assessment (SOFA) score from 0 (normal) to a range of 1-4 with higher scores indicating more severe organ dysfunction | From start to end of alteplase infusion/ equivalent timeframe in controls |
Frequently Asked Questions
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