Point-of-care diagnosis and monitoring of fibrinolysis resistance in the critically ill: results from a feasibility study.
Lucy A Coupland, David J Rabbolini, Jonathan G Schoenecker...
https://pubmed.ncbi.nlm.nih.gov/36765421Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID06680180
Fibrinolysis Resistance in Infection and Trauma Using Viscoelastic Testing to Guide Personalized Treatment in ICU Patients
Led by Anders Aneman · Updated on 2024-11-08
150
Participants Needed
4
Research Sites
21 weeks
Total Duration
On this page
Sponsors
A
Anders Aneman
Lead Sponsor
L
Liverpool Hospital, South Western Sydney Local Health District
Collaborating Sponsor
AI-Summary
What this Trial Is About
Blood clotting problems often occur in critically ill patients, such as those with severe infections or serious injuries, which can lead to life-threatening complications like organ failure due to excessive clot formation. This research is focused on using Viscoelastic Testing (VET) technology to identify patients at risk of excessive clotting, evaluate new blood clotting drugs, and guide the use of blood-altering treatments in critical care settings. The study aims to better understand why fibrinolysis resistance happens in severe infections and trauma, which may improve personalized treatment approaches. The study uses Viscoelastic Testing technology called ClotPro4 to assess blood clot breakdown activity by analyzing key proteins involved in fibrinolysis. It observes patients with sepsis or trauma admitted to intensive care units (ICUs) who meet specific clinical criteria, including those expected to stay in ICU beyond the immediate days and requiring organ support or blood transfusion risk. The project involves testing blood samples at multiple time points after ICU admission to study clotting activity and response to potential treatments. Participants will undergo blood testing using VET at admission and at 24 hours, 48 hours, 5, 7, 10, and 15 days after ICU admission. Researchers will analyze blood clotting and fibrinolysis profiles to detect abnormalities and understand enzyme activity changes. The study will monitor patients closely in ICU with laboratory evaluations and data collection to inform future clinical trials aimed at personalizing treatment for fibrinolysis resistance. Total participation time varies depending on ICU stay and recovery.
CONDITIONS
Brief Title
Fibrinolysis Resistance in Infection and Trauma
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Admission to ICU needing at least one organ support for clinically suspected sepsis or septic shock according to Sepsis-3 criteria
- Expected to remain in ICU and survive beyond the day after tomorrow
- Trauma is the principal diagnosis on ICU admission
- Receiving respiratory support at ICU admission (high-flow nasal prongs, non-invasive or invasive ventilation)
- Already received or considered at risk of needing blood product transfusion within 24 hours of injury
You will not qualify if you...
- Currently on oral anticoagulant or antiplatelet therapy
- Not for full, active ICU support
- Death is deemed inevitable within 24 hours
- Nursing home resident (for trauma group)
- Unsurvivable head injury (for trauma group)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 15 days from ICU admission
Participants undergo viscoelastometric testing and laboratory evaluation to assess fibrinolysis capacity and enzyme activity.
7 visits at admission, 24 hours, 48 hours, 5 days, 7 days, 10 days, and 15 days post ICU admission
Long-term Monitoring
Duration - Up to 15 days from ICU admission
Participants are monitored to understand fibrinolysis resistance mechanisms and potential treatment options in severe infection and trauma.
Includes assessments coinciding with diagnostic evaluations during ICU stay
Trial Site Locations
Total: 4 locations
1
The Canberra hospital (ICU)
Canberra, Australian Capital Territory, Australia, 2605
Actively Recruiting
2
Liverpool Hospital (ICU)
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
3
Macquarie University Hospital (ICU)
Macquarie, New South Wales, Australia, 2109
Actively Recruiting
4
Royal North Shore Hospital (ICU)
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
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Research Team
A
Anders Aneman, MD, PhD, EDIC, FCICM
L
Lucy Coupland, Nurs Cert, BSci (hons), PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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