Critical Illness, Fibrinolytic Defect, Sepsis
Conditions
Brief summary
Impaired fibrinolysis in septic patients is associated with worse outcome. The present study investigates fibrinolysis shutdown in septic patients, defined as prolonged ClotPro® TPA lysis time at 30 minutes. The TPA lysis time reference range is established in a cohort of healthy volunteers.
Interventions
DIAGNOSTIC_TESTClot Pro
This study enrolls patients admitted to the Adult ICU of Milan Policlinico Hospital with a diagnosis of sepsis or septic shock. A ClotPro® TPA test is performed at admission and on day 1, 2, 3, and 7. Specific markers of coagulation (PAI-1, Plasminogen, Protein C and S) and inflammation (Il-1beta, IL-6, IL-8, TNF-alpha, ADM) are tested at enrollment. Routine laboratory tests are performed daily. Hemorrhagic and thrombotic events are searched. The study ends at 28 days or upon ICU discharge.
Sponsors
Policlinico Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age \> 18 years * sepsis or septic shock * vasopressors required to maintain a MAP ≥ 65 mmHg despite adequate fluid resuscitation
Exclusion criteria
* coagulation disorders * ECMO therapy * use of oral anticoagulant drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of impaired fibrinolysis | Lysis time at 30 minutes at enrollment and on day 1, 2, 3, and 7 | Lysis time at 30 minutes longer than 97.5th percentile of the calculated reference range of the ClotPro® TPA test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between impaired fibrinolysis and changes in coagulation standard tests | Measures are performed at enrollment and on day 1, 2, 3, and 7 | Number of patients with impaired fibrinolysis who have other abnormalities in standard coagulation tests (increased PT and PTT, decreased platelet count, increased D-dimer and decreased fibrinogen) |
| Correlation between impaired fibrinolysis and inflammation markers | Measures are performed at enrollment and on day 1, 2, 3, and 7 | Number of patients with impaired fibrinolysis who have increased serum C-reactive protein and/or procalcitonin |
| Correlation between impaired fibrinolysis and multiorgan failure | Measures are performed at enrollment and on day 1, 2, 3, and 7 | Number of patients with impaired fibrinolysos who develop multiorgan failure, defined as SOFA score \> 5 |
| Correlation between impaired fibrinolysis and ICU lenght of stay | Through study completion, an average of 1 year | Differential in number of days in ICU in patients with and without impaired fibrinolysis |
| Correlation between impaired fibrinolysis and ICU mortality | From date of enrollment until date of ICU discharge or date of death from any cause, whichever comes first, assessed up to 1 year | Mortality rate in patients with and without impaired fibrinolysis |
Countries
Italy
Outcome results
None listed