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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Septic patients | Other |
| |
| Healthy volunteers | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clot Pro | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of impaired fibrinolysis | Lysis time at 30 minutes longer than 97.5th percentile of the calculated reference range of the ClotPro® TPA test | Lysis time at 30 minutes at enrollment and on day 1, 2, 3, and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between impaired fibrinolysis and changes in coagulation standard tests | 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) | Measures are performed at enrollment and on day 1, 2, 3, and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Trend of fibrinolysis in the first ICU week with repeated ClotPro® tests | Variation of TPA lysis time | ClotPro® tests are performed at enrollment and on day 1, 2, 3, and 7 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | MI | 20100 | Italy |
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| ID | Term |
|---|---|
| C565017 | Fibrinolytic Defect |
| D018805 | Sepsis |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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|
| Correlation between impaired fibrinolysis and inflammation markers | Number of patients with impaired fibrinolysis who have increased serum C-reactive protein and/or procalcitonin | Measures are performed at enrollment and on day 1, 2, 3, and 7 |
| Correlation between impaired fibrinolysis and multiorgan failure | Number of patients with impaired fibrinolysos who develop multiorgan failure, defined as SOFA score > 5 | Measures are performed at enrollment and on day 1, 2, 3, and 7 |
| Correlation between impaired fibrinolysis and ICU lenght of stay | Differential in number of days in ICU in patients with and without impaired fibrinolysis | Through study completion, an average of 1 year |
| Correlation between impaired fibrinolysis and ICU mortality | Mortality rate in patients with and without impaired fibrinolysis | From date of enrollment until date of ICU discharge or date of death from any cause, whichever comes first, assessed up to 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |