An interventional study of Clot Pro in Fibrinolytic Defect, Sepsis and Critical Illness, sponsored by Policlinico Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Policlinico Hospital · Not applicable, Interventional, and Diagnostic
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's enrollment of 100 is close to the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Policlinico Hospital is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Diagnostic Test: Clot Pro
Diagnostic Test: Clot 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.
Prevalence of impaired fibrinolysis
Lysis time at 30 minutes longer than 97.5th percentile of the calculated reference range of the ClotPro® TPA test
Time frame: Lysis time at 30 minutes at enrollment and on day 1, 2, 3, and 7
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)
Time frame: Measures are performed at enrollment and on day 1, 2, 3, and 7
Correlation between impaired fibrinolysis and inflammation markers
Number of patients with impaired fibrinolysis who have increased serum C-reactive protein and/or procalcitonin
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1 year
Correlation between impaired fibrinolysis and ICU mortality
Mortality rate in patients with and without impaired fibrinolysis
Time frame: From date of enrollment until date of ICU discharge or date of death from any cause, whichever comes first, assessed up to 1 year
Trend of fibrinolysis in the first ICU week with repeated ClotPro® tests
Variation of TPA lysis time
Time frame: ClotPro® tests are performed at enrollment and on day 1, 2, 3, and 7
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Mar 2025, 14 months.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 14 months is below that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Policlinico Hospital