Point of Care Evaluation of Fibrinolysis in Sepsis

NCT06312488 | Completed

• 1 other identifier: 4097
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibrinolytic Defect; Sepsis; Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Correlation between impaired fibrinolysis and changes in coagulation standard tests

  Measures are performed at enrollment and on day 1, 2, 3, and 7

• Correlation between impaired fibrinolysis and inflammation markers

  Measures are performed at enrollment and on day 1, 2, 3, and 7

• Correlation between impaired fibrinolysis and multiorgan failure

  Measures are performed at enrollment and on day 1, 2, 3, and 7

• Correlation between impaired fibrinolysis and ICU lenght of stay

  Through study completion, an average of 1 year

• Correlation between impaired fibrinolysis and ICU mortality

  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 Outcomes (1)

• Trend of fibrinolysis in the first ICU week with repeated ClotPro® tests

  ClotPro® tests are performed at enrollment and on day 1, 2, 3, and 7

Study Arms (2)

Septic patients

OTHER

Diagnostic Test: Clot Pro

Healthy volunteers

OTHER

Diagnostic Test: Clot Pro

Interventions

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.

Healthy volunteers; Septic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years
• sepsis or septic shock
• vasopressors required to maintain a MAP ≥ 65 mmHg despite adequate fluid resuscitation

You may not qualify if:

• coagulation disorders
• ECMO therapy
• use of oral anticoagulant drugs

Sponsors & Collaborators

• Policlinico Hospital: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, 20100, Italy

Location

MeSH Terms

Conditions

Fibrinolytic Defect; Sepsis; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: March 15, 2024
• Study Start: January 22, 2024
• Primary Completion: March 31, 2025
• Study Completion: November 30, 2025
• Last Updated: April 8, 2026

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)