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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06680180
Registration number
NCT06680180
Ethics application status
Date submitted
9/10/2024
Date registered
8/11/2024
Date last updated
8/11/2024
Titles & IDs
Public title
Fibrinolysis Resistance in Infection and Trauma
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Scientific title
Fibrinolysis Resistance in Infection and Trauma
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Secondary ID [1]
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2022/ETH02122
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Universal Trial Number (UTN)
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Trial acronym
FORTITUDE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sepsis and Septic Shock
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Trauma
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Condition category
Condition code
Skin
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Other skin conditions
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Viscoelastometric assessment of fibrinolysis
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.
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.
Diagnosis / Prognosis: 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.
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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VET testing and analysis
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Assessment method [1]
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VET testing in whole blood will determine the kinetics and contribution of: i) both plasma and platelets to clot formation following the addition of tissue factor. ii) plasma clot formation only by adding tissue factor and platelet inhibitors. iii) tPA-induced fibrinolysis by adding tissue factor and tPA. The following test parameters will be used for analytical purposes: clotting time, clot amplitude at 10 min, maximum clot firmness, lysis time, maximum lysis. The platelet contribution to the clot will be calculated by subtracting (ii) from (i). An additional blood sample will be collected at the time of VET analysis for processing and storage for subsequent fibrinolysis protein analysis.
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Timepoint [1]
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From admission to ICU and at 24 hours, 48 hours, 5 days, 7 days, 10 days, and 15 days post ICU admission
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Primary outcome [2]
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Laboratory evaluation of fibrinolytic profile
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Assessment method [2]
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We will evaluate the temporal changes in key fibrinolytic markers (i.e. plasminogen, antiplasmin, PAI-1 activity) and also changes in overall fibrinolytic capacity of patient plasma (i.e. how responsive plasma is to generate plasmin ex vivo) in relation to the VET testing. Commercial ELISAs will be used to determine plasminogen, alpha2 antiplasmin levels, PAI-1 and tPA activity; A novel tPA inducible plasmin-antiplasmin test will be used to evaluate plasmin generation; amidolytic assay will be used to determine plasmin activity.
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Timepoint [2]
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From admission to ICU and at 24 hours, 48 hours, 5 days, 7 days, 10 days, and 15 days post ICU admission
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Eligibility
Key inclusion criteria
Sepsis/Septic shock
* Admission to ICU, needing at least one organ supportand principally for the management of clinically suspected Sepsis or Septic shock according to Spesis-3 criteria (including SARS-COV-2)
* Expected to remain in ICU and survive beyond the day after tomorrow
Sepsis
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* On oral anticoagulant/antiplatelet therapy
* Not for full, active ICU support
* Death is deemed inevitable within 24 hrs
Trauma Inclusion Criteria:
* 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
Trauma
* Nursing home resident
* Unsurvivable head injury
* Not for full, active ICU support
* Death is deemed inevitable within 24 hrs
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2026
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW
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Recruitment hospital [1]
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The Canberra hospital (ICU) - Canberra
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Recruitment hospital [2]
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Liverpool Hospital (ICU) - Liverpool
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Recruitment hospital [3]
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Macquarie University Hospital (ICU) - Macquarie
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Recruitment hospital [4]
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Royal North Shore Hospital (ICU) - St Leonards
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Recruitment postcode(s) [1]
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2605 - Canberra
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Recruitment postcode(s) [2]
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2170 - Liverpool
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Recruitment postcode(s) [3]
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2109 - Macquarie
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Recruitment postcode(s) [4]
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2065 - St Leonards
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Funding & Sponsors
Primary sponsor type
Other
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Name
Anders Aneman
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Liverpool Hospital, South Western Sydney Local Health District
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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The Canberra Hospital
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Royal North Shore Hospital
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Macquarie University, Australia
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Address [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
Blood coagulation disorders are often seen in critically ill patients e.g. with severe infection or following extensive injury, that can lead to life threatening events as a result of excessive blood clot formation leading to organ failure. This study aims to use Viscoelastic Testing (VET) technology to detect patients at risk of excessive blood blot formation at the bedside, test new blood coagulation drugs, and guide life-saving use of blood modifying treatments.
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Trial website
https://clinicaltrials.gov/study/NCT06680180
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Anders Aneman, MD, PhD, EDIC, FCICM
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Address
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Country
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Phone
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+61427915693
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06680180
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