Fibrinolysis Resistance in Infection and Trauma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnders Aneman
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
On oral anticoagulant/antiplatelet therapy
Not for full, active ICU support
Death is deemed inevitable within 24 hrs
Trauma is the principal diagnosis on ICU admission
Trial population
Patients who are admitted to an ICU
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Viscoelastometric assessment of fibrinolysis
Diagnostic testViscoelastometric assessment of whole blood fibrinolysis using supplemental tissue plasminogen activator (tPA) and other agents ex vivo to influence fibrinolysis capacity.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Sepsis/Septic shock1 intervention
Group B: Severe Trauma1 intervention
Trial outcomes
Primary outcomes
1
VET testing and analysis
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.
Time frame
From admission to ICU and at 24 hours, 48 hours, 5 days, 7 days, 10 days, and 15 days post ICU admission2
Laboratory evaluation of fibrinolytic profile
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.
Time frame
From admission to ICU and at 24 hours, 48 hours, 5 days, 7 days, 10 days, and 15 days post ICU admissionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Anders Aneman
Lead sponsor
South West Sydney Local Health District
Sponsor institution
Liverpool Hospital, South Western Sydney Local Health District
Collaborator
The Canberra Hospital
Collaborator
Royal North Shore Hospital
Collaborator
Macquarie University, Australia
Collaborator
Source ClinicalTrials.gov