Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2024-06-01
2026-06-01
Brief Summary
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Detailed Description
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The viscoelastic testing (VET) technology ClotPro® has been used to identify fibrinolysis resistance in 55% of critically ill patients (COVID and non-COVID with acute respiratory failure) and through novel adaptation of the technology, determined that this is likely driven by reduced tPA and/or plasminogen activity. Furthermore, it has been used to detect in real time the impact of a 24 hr tPA infusion on fibrinolysis in a patient. Thus, this preliminary work has demonstrated the feasibility of a personalised treatment approach to fibrinolysis resistance management that can guide life-saving use of fibrinolysis enhancers to overcome resistance in an individualised basis that is likely to increase therapeutic efficacy and safety.
This project aims to scientifically validate the aforementioned preliminary work, increase our knowledge on the mechanisms of reduced fibrinolysis enzyme activity in severe infection and injury, discover potential treatment options, and progress these findings towards translation. The results of this project will drive future clinical trials of repurposed or novel therapies guided by VET to deliver a personalised dose to critically ill patients who demonstrate fibrinolysis resistance, which in conjunction with rapid detection, is anticipated to significantly improve patient outcomes.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sepsis/Septic shock
According to Sepsis-3 definitions (including SARS CoV-2 as pathogen); expected to remain in ICU and survive beyond the day after tomorrow and for full, active ICU treatment; arterial and secure venous access established or imminent as part of standard care; not on oral anticoagulant/antiplatelet therapy.
Viscoelastometric assessment of fibrinolysis
Viscoelastometric assessment of whole blood fibrinolysis using supplemental tissue plasminogen activator (tPA) and other agents ex vivo to influence fibrinolysis capacity.
Severe Trauma
Admitted via the Emergency Department resuscitation bay requiring trauma team response; deemed at risk of significant blood loss and where transfusion of blood products i considered in the ED during the acute phase of the resuscitation by a senior clinician; expected to remain in ICH and survive beyond the day after tomorrow and for full, active ICU treatment; Not on oral anticoagulant/antiplatelet therapy. A clinical based inclusion approach is the most pragmatic means of patient selection and can be objectively supported by routine blood tests demonstrating poor oxygen supply to the organs. Exclusion criteria: unsurvivable head injury.
Viscoelastometric assessment of fibrinolysis
Viscoelastometric assessment of whole blood fibrinolysis using supplemental tissue plasminogen activator (tPA) and other agents ex vivo to influence fibrinolysis capacity.
Interventions
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Viscoelastometric assessment of fibrinolysis
Viscoelastometric assessment of whole blood fibrinolysis using supplemental tissue plasminogen activator (tPA) and other agents ex vivo to influence fibrinolysis capacity.
Eligibility Criteria
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Inclusion Criteria
* Expected to remain in ICU and survive beyond the day after tomorrow
* Trauma is the principal diagnosis on ICU admission
* Expected to remain in ICU and survive beyond the day after tomorrow
* Receiving respiratory support at the time of ICU admission - high-flow nasal prongs, non-invasive or invasive ventilation
* Already received, or considered at risk of needing a blood product transfusion within 24 hrs of injury
Exclusion Criteria
* Not for full, active ICU support
* Death is deemed inevitable within 24 hrs
* Nursing home resident
* Unsurvivable head injury
* Not for full, active ICU support
* Death is deemed inevitable within 24 hrs
18 Years
ALL
Yes
Sponsors
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Liverpool Hospital, South Western Sydney Local Health District
UNKNOWN
The Canberra Hospital
OTHER
Royal North Shore Hospital
OTHER
Macquarie University, Australia
OTHER
Anders Aneman
OTHER
Responsible Party
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Anders Aneman
Conjoint Professor
Locations
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The Canberra hospital (ICU)
Canberra, Australian Capital Territory, Australia
Liverpool Hospital (ICU)
Liverpool, New South Wales, Australia
Macquarie University Hospital (ICU)
Macquarie, New South Wales, Australia
Royal North Shore Hospital (ICU)
St Leonards, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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Coupland LA, Rabbolini DJ, Schoenecker JG, Crispin PJ, Miller JJ, Ghent T, Medcalf RL, Aneman AE. Point-of-care diagnosis and monitoring of fibrinolysis resistance in the critically ill: results from a feasibility study. Crit Care. 2023 Feb 10;27(1):55. doi: 10.1186/s13054-023-04329-5.
Other Identifiers
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2022/ETH02122
Identifier Type: -
Identifier Source: org_study_id
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