Point of Care Evaluation of Fibrinolysis in Sepsis (POCEFIS)

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 Overview

• Status: Completed
• Conditions: Sepsis; Critical Illness; Fibrinolytic Defect
• Intervention / Treatment: Diagnostic test: Clot Pro

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20100
      • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy volunteers	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.
Other: Septic patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Policlinico Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Critical Illness; Sepsis; Fibrinolytic Defect
• Other Study ID Numbers: 4097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No