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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06312488
Other study ID # 4097
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 22, 2024
Est. completion date August 31, 2025

Study information

Verified date March 2024
Source Policlinico Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan MI

Sponsors (1)

Lead Sponsor Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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