Point of Care Evaluation of Fibrinolysis in Sepsis

Policlinico Hospital100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Fibrinolytic Defect Sepsis Critical Illness

Interventions

Clot ProDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, Italy

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.